System for implanting an implant and method thereof

ABSTRACT

A system for implanting an implant and method thereof is disclosed. In general overview, the system includes an implant, an envelope enclosing the implant, a delivery assembly and an attachment piece for attaching the envelope or implant to the delivery assembly. The envelope may include a drug coating, positioning aids, and means to ease envelope removal. In one embodiment, the delivery assembly is employed for implant and/or envelope delivery inside the patient&#39;s body. In another embodiment, the delivery assembly and an attachment piece are employed to deliver the implant or the envelope inside the patient&#39;s body.

[0001] This application is based on and claims priority to provisionalpatent application Serial No. 60/274,843 filed in the United StatesPatent Office on Mar. 9, 2001 and provisional patent application SerialNo. 60/286,863 filed in the United States Patent Office on Apr. 26,2001, the entire contents of which are incorporated by reference herein.

TECHNICAL FIELD

[0002] The invention relates generally to a system for implanting adevice such as a surgical mesh at an anatomical site in the body of apatient. More particularly, the invention relates to a surgical meshenclosed within an envelope and a system for delivering the envelope andmesh to an anatomical site in the patient's body.

BACKGROUND INFORMATION

[0003] The use of a surgical mesh for the repair and restoration ofliving tissue is well known. For example, surgical mesh may be used tosupport and/or reinforce a damaged or weakened portion in the body of apatient. In this regard, the surgical mesh must additionally besufficiently porous to allow for growth of tissue through the mesh afterimplantation. The healing tissue grows through porous openings in, forexample, an implanted synthetic mesh, thereby assimilating the tissuewith the mesh and adding structural integrity to the tissue.

[0004] Surgical meshes may be produced with yams including monofilamentand multifilament yams. Multifilament yams have small void areas orinterstitial spaces between the yam filaments. The yams in the surgicalmesh may be made of materials such as polypropylene, polyesters, andco-polymers thereof. Such polymeric materials typically do not havesurface structures that are absorbent or adsorbent; thus, meshes madeout of such materials are unable to absorb drugs.

[0005] The crevices and voids of the surgical mesh may harbor bacteriaor other pathogens that contaminate the surgical mesh duringimplantation. Following implantation of the surgical mesh in thepatient, the bacteria or other pathogens harbored in the mesh areintroduced to the anatomical site where the surgical mesh is implanted.Typically, the anatomical site being repaired is poorly accessible toantimicrobial drugs applied intraoperatively to combat bacteria or otherpathogens that may be picked up and introduced to the anatomical siteduring the surgery to implant the mesh.

SUMMARY OF THE INVENTION

[0006] The present invention relates to devices, delivery systems andmethods for implanting an implant, such as a sling, at an anatomicalsite in the body of a patient, such as at the mid-urethra, and methodsof making such devices and delivery systems. The devices and deliverysystems are relatively inexpensive, provide effective therapy, and theiruse requires minimal training. In one embodiment of the invention, thedevices, delivery systems, and methods of the invention can be used totreat female urinary incontinence, including stress incontinence. Thebenefits of the invention described herein include a delivery systemthat minimizes or prevents contamination of the implant and minimizes orprevents contamination of the patient's tissue while simultaneouslyintroducing a therapeutic agent or drug such as an antibiotic to thepatient's tissues during delivery of the implant to the anatomical site.Moreover, the system according to the invention, allows the operator toadjust and position the implant at the anatomical site in the patient'sbody and to maintain the correct position of the implant at theanatomical site during and after removal of the delivery system. Inaddition, the system, according to the invention, provides a simplemeans for attaching the implant to a delivery assembly. The deliveryassembly can be used for a plurality of surgical approaches to theurethra such as a transvaginal and a transabdominal approach (e.g.,percutaneous) and assists the operator in accurate positioning of theimplant at the anatomical site in the patient's body.

[0007] In one aspect, the invention includes a system for implanting animplant in a body. In one embodiment of the invention, the deliverysystem includes a delivery assembly and an attachment piece. In anotherembodiment, the delivery system further includes an envelope having aninner surface and an outer surface enclosing the implant. At least oneof the inner or outer surface of the envelope includes at least onetherapeutic agent, for example, an antimicrobial drug, such as anantibiotic. In one embodiment according to the invention, the materialused to make the envelope is an absorbent material. Alternatively, thematerial used to make the envelope is selected from the group includingpolypropylene, polyethylene, polyester, polytetrafluoroethylene (e.g.,TEFLON®), TYVEK®, MYLAR®, and co-polymers, thereof. In yet anotherembodiment, the envelope may be coated on the inner or the outer surfacewith a hydrophilic or a hydrophobic agent. The coating may be selectedfrom the group consisting of synthetic coatings and natural coatings,one or more of which may be an absorbent coating.

[0008] In one embodiment according to the invention, the envelopeincludes a tearable region such as a region of the envelope havingapertures, for example, slits or cuts. Alternatively, at least a portionof the envelope includes a tearable material, i.e., a material that maybe pulled apart into pieces by application of some force, such as amaterial having a highly oriented molecular orientation, for example, alinear molecular orientation. In yet another embodiment, the envelope isa composite of a first material and a second material, for example, acomposite of a tearable material and a material that does not tear. Thetearable region may include a seam where a first material of a firstside and a second material of a second side are coupled to form anenvelope. Alternatively, the tearable region may include an external tabthat is adjacent the envelope outer surface. When the tab is pulled theenvelope tears. In another embodiment the tearable region includes aninternal tab that is enclosed within the inner surface of the envelope.The internal tab tears the envelope when pulled.

[0009] In another embodiment of the invention, the envelope includes atleast two sleeves. The two sleeves may include at least one pull tab. Inone embodiment, the sleeves include at least one hinge section. In thisembodiment of the invention, the hinge section of one sleeve may becoupled to the hinge section of the other sleeve. In another embodimentaccording to the invention, the system includes a spacer, such as aclamp, for joining two or more sleeves. The clamp may include a bulkmaterial, a balloon or a pressure sensor.

[0010] In yet another embodiment, the envelope includes at least onepositioning member for positioning the implant at the anatomical site inthe body of the patient. In another embodiment, the envelope includes atleast one attachment piece.

[0011] In one embodiment according to the invention, an antimicrobialdrug, for example, an antibiotic, is disposed on the inner surface ofthe envelope. Alternatively, or in addition, an antimicrobial drug isdisposed on the outer surface of the envelope. The envelope may bemanufactured from absorbent materials and the drug may be absorbedthrough this absorbent material to both the inner and outer surfaces ofthe envelope.

[0012] In another embodiment according to the invention, the drug, suchas an antibiotic, may be bonded to or may associate with the envelopematerial or with the one or more coatings applied to the inner or outersurface of the envelope. Alternatively, the one or more surface coatingsmay be absorbent and absorb the drug. The release and delivery of thedrug from the envelope surface to the anatomical site of the patient'sbody will depend, in part, on the bonding affinity shared by the drugand the coating. When the bond is relatively weak, the drug will bereleased from the envelope more readily than when the bond is relativelystrong.

[0013] In another aspect, the system according to the invention includesthe envelope configured to enclose an implant, and a spacer disposed onat least one of said inner surface or outer surfaces of the envelopethat is useful for positioning the implant at an anatomical site in thebody of a patient. In one embodiment of the invention, the spacerincludes a bulk material, such as a hydrogel, polyethylene, orcellulose. In another embodiment, the spacer includes a balloon that maybe filled with a gas or liquid. In yet another embodiment, the spacer isa clamp including a first member and a second member. The thickness of,for example, the first member may provide the spacer thickness that isuseful for positioning the implant. Alternatively, a balloon or a bulkmaterial may be added to the exterior surface of the first member of theclamp to adjust the spacer thickness. In yet another embodiment, thesystem according to the invention includes a pressure sensor positioned,for example, at the spacer, for determining the amount of tensionapplied to the implant after the implant is positioned in the body. Inaddition, the pressure sensor may reveal the amount of tension appliedto the envelope or alternatively the amount of tension applied to theimplant.

[0014] In another aspect, the system according to the invention includesan envelope including two sleeves configured to enclose the implant, anda clamp for coupling together the two sleeves. The clamp includes afirst member and a second member. In one embodiment of the invention, aportion of the sleeves overlaps and the clamp secures together theoverlapping portions of the sleeves. The clamp may releasably couple thesleeves. In this embodiment, the sleeves may be the same or differentlengths. In one embodiment the two or more sleeves are the same length.

[0015] In another aspect, the system according to the invention includesthe envelope enclosing the implant, the envelope further includes atleast one tab joined at a first or second end of the envelope forpositioning the implant in the body. In one embodiment, the tab is apositioning member for positioning the implant in the body of thepatient. The envelope may include two or more sleeves and a hinge. Inanother embodiment, the envelope having two or more sleeves and/or ahinge includes at least one attachment piece. In yet another embodiment,each sleeve may include a hinge section, the hinge sections of twosleeves may be coupled to one another.

[0016] In another aspect of the invention, an attachment piece isprovided for joining an implant, such as a sling, to a deliveryassembly. The attachment piece includes a first member bonded to theimplant. The first member engageable with a second member wherein thefirst member is seated in the second member to join the implant to thedelivery assembly. In another embodiment, the first member of theattachment piece includes an appendage to which the implant is bonded.The appendage and the first member may be manufactured from polyethyleneand may be bonded to the implant by an adhesive, by suturing, or by heatbonding. In one embodiment, the appendage includes a free end that isbonded to the implant.

[0017] In another aspect of the invention, the system includes adelivery assembly for delivering an implant to an anatomical site in thebody of a patient. In one embodiment, the delivery assembly includes aretractable point, a delivery handle including a proximal button, and adistal button. The proximal and distal buttons are operatively joined tothe retractable point. Each of the proximal button and the distal buttonmove the retractable point from a first position to a second position.In one embodiment of the invention, the delivery assembly furtherincludes a cannula having a lumen. The cannula may include an arc. Theretractable point of the delivery assembly may be positioned in thelumen of the cannula.

[0018] In yet another embodiment of this aspect of the invention, thedelivery assembly may further include a dilator tube and an extenderbutton positioned on the elongated body portion of the delivery handle.The extender button is operatively joined to the dilator tube andextends and retracts the dilator tube from the distal end of theelongated body portion of the delivery handle. The dilator tube includesa hollow member. In one embodiment, the hollow member further includes arigid ring attached to the wall of the hollow member.

[0019] In another embodiment of the invention, the dilator tube includesa conical tip. The conical tip includes a hinge and the hinge may be aportion of the wall of the tube. In one embodiment according to theinvention, the first member of the attachment piece is sized and shapedto fit within the lumen of the dilator tube. The first member includes afirst and second portion enclosed by the dilator tube when the firstmember and dilator tube are anchored together. In one embodiment of theinvention, the first member includes a first end having a slit. In oneembodiment, when the first member is anchored in the dilator tube, theappendage is positioned between the conical tip and the tube. In anotherembodiment, the conical tip is sized and shaped to be seated on thefirst portion of the first member to anchor the first member to thedilator tube. In yet another embodiment, when the first member and thedilator tube are engaged, the first portion of the first member extendsfrom the lumen of the dilator tube. The conical tip is positioned at thetissue piercing end of the delivery assembly and may also include anaperture. The aperture may provide an opening through which a cannulamay emerge.

[0020] In another aspect, the invention relates to a method forpositioning an implant at an anatomical site in the body of a patient.In this method, a system is provided that includes an implant and anenvelope. The envelope is configured to enclose the implant and includesa drug disposed on at least one of an inner or an outer surface of theenvelope. The system is inserted in the patient's body to an anatomicalsite to be treated. The drug is released from the envelope and deliveredto the anatomical site in the patient's body. The implant is positionedat the anatomical site and the envelope is removed from the patient'sbody. After removal of the envelope, the implant remains where it waspositioned at the anatomical site. In one embodiment of the method ofthe invention, the implant is positioned at the mid-urethra of thepatient to treat, for example, female urinary incontinence. In aparticular embodiment, the envelope has a visible indication mark on orat least visible from the envelope outer surface to assist the operatorpositioning the implant at the anatomical site in the body of thepatient.

[0021] It is a further object of the method of the invention to providean envelope enclosing an implant, such as a surgical mesh, to a damagedportion of a patient's body, wherein the envelope delivers drugs to thedamaged area upon placement of the surgical mesh inside the patient'sbody. The surgical mesh may be, for example, a sling or other type ofmesh that is shaped to fit the mid-urethra of a female patient.

[0022] In another aspect, the invention includes a method of positioningan implant at an anatomical site in the body of a patient. In oneembodiment of the method, a system includes an envelope having at leasttwo sleeves enclosing an implant, and a clamp that couples the sleevestogether. The system is inserted into the patient's body and positionedat the anatomical site to be treated. Once the system enclosing theimplant is positioned, the clamp is unfastened and removed from thepatient's body followed by uncoupling and removal of the sleeves fromthe patient's body. The implant remains positioned at the anatomicalsite to be treated in the patient's body.

[0023] In another aspect, the invention is a method for positioning animplant at an anatomical site in the body of a patient. According tothis method of the invention, a system is provided including an envelopehaving a lumen sized to enclose the implant and a tab disposed at eachof a first end and a second end of the envelope. The operator insertsthe system in the body of the patient, grasps the tabs disposed at eachof the first and second ends of the envelope, positions the implant inthe body, and removes the envelope from the body. In one embodiment thetab includes a positioning member for positioning the envelope enclosingan implant in the patient's body. The envelope may include a visualindication mark or a positioning mark for positioning the implant in thepatient's body.

[0024] In another aspect, the invention is a method for delivering animplant to an anatomical site in the body of a patient. According tothis method, the operator attaches the implant to the attachment piece,and the attachment piece is secured to the delivery assembly. In oneembodiment where the attachment piece is pre-attached to the envelope,the operator attaches the pre-attached attachment piece and envelopeonto the delivery assembly, to form the delivery system. In oneembodiment, the delivery assembly includes a handle, a retractablepoint, a proximal button, and a distal button. Alternatively, thedelivery assembly further includes a dilator tube and an extenderbutton. The retractable point is extended by actuating or moving eitherthe proximal or the distal button. In one embodiment, the implantattached to the delivery assembly provides the delivery system, and thedelivery system is introduced into the body of the patient andpositioned at the anatomical site. The implant is detached from thedelivery assembly and the delivery assembly is withdrawn. In anotherembodiment, the delivery assembly is introduced into the body of thepatient then the implant is attached to the delivery assembly andpositioned at the anatomical site. Thereafter the implant is detachedfrom the delivery assembly and the delivery assembly is withdrawn fromthe body of the patient. In another embodiment of the invention themethod further includes grasping the tabs at the end of the envelope andtearing the envelope to remove it from the implant and then from thebody.

[0025] The foregoing and other objects, aspects, features, andadvantages of the invention will become more apparent from the followingdescription and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In the drawings, like reference characters generally refer to thesame parts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

[0027]FIG. 1A illustrates a perspective view of a delivery system forimplanting an implant in a body.

[0028]FIG. 1B illustrates a top view of a longitudinal section of oneembodiment of a system for implanting an implant in a body.

[0029]FIG. 1C illustrates a cross section at 1C-1C of the system forimplanting an implant in a body, illustrated in FIG. 1A.

[0030]FIG. 2A illustrates a top view of a longitudinal section ofanother embodiment of the system for implanting an implant in a bodywhere drugs are absorbed by a surface coating on the inside of anenvelope.

[0031]FIG. 2B illustrates a cross section at 2B-2B of the system forimplanting an implant in a body illustrated in FIG. 2A.

[0032]FIG. 3A illustrates another embodiment of the longitudinal sectionof the system illustrated in FIG. 2A including apertures to permit theinside surface of the envelope to contact a drug solution and a tearfeature.

[0033]FIG. 3B illustrates a cross section at 3B-3B of the system forimplanting an implant in a body illustrated in FIG. 3A.

[0034]FIG. 4A illustrates a first side of a system for implanting animplant.

[0035]FIG. 4B illustrates a second side of a system for implanting animplant.

[0036]FIG. 4C illustrates the side view of a system for implanting animplant in a body including the first side illustrated in FIG. 4A andthe second side illustrated in FIG. 4B.

[0037]FIG. 4D illustrates a system for implanting an implant in a bodyincluding the first side illustrated in FIG. 4A and the second sideillustrated in FIG. 4B.

[0038]FIG. 4E illustrates another embodiment of a system for implantingan implant in a body including the first side illustrated in FIG. 4A andthe second side illustrated in FIG. 4B.

[0039]FIG. 4F illustrates a cross section at 4F-4F of the system forimplanting an implant in a body illustrated in FIG. 4E.

[0040]FIG. 4G illustrates a cross section of another embodiment of asystem for implanting an implant in a body including the first sideillustrated in FIG. 4A and the second side illustrated in FIG. 4B.

[0041]FIG. 5A illustrates a side view of an embodiment of a systemaccording to the invention including a clamp.

[0042]FIG. 5B illustrates a side view of one embodiment of a clampaccording to the invention.

[0043]FIG. 5C illustrates a side view of another embodiment of a clampaccording to the invention.

[0044]FIG. 5D illustrates a top view of an embodiment of a systemaccording to the invention including a clamp illustrated in FIG. 5A.

[0045]FIG. 5E illustrates a side view of another embodiment of a systemaccording to the invention for implanting an implant in a body includinga bulk material disposed on the surface of the envelope.

[0046]FIG. 5F illustrates a side view of another embodiment of a systemaccording to the invention for implanting an implant in a body includinga balloon on the surface of the envelope.

[0047]FIG. 5G illustrates the system for implanting an implant in a bodyillustrated in FIG. 5F with the balloon filled.

[0048]FIG. 5H illustrates an embodiment of the clamp illustrated in FIG.5A including a filled balloon.

[0049]FIG. 5I illustrates an embodiment of the clamp illustrated in FIG.5A where the first member of the clamp includes a bulk material.

[0050]FIG. 6 illustrates an embodiment of the system illustrated inFIGS. 5F-5G for implanting an implant in a body.

[0051]FIG. 7A illustrates another embodiment of the system forimplanting an implant in a body.

[0052]FIG. 7B illustrates the system shown in FIG. 7A including asurgical mesh.

[0053]FIG. 7C illustrates the system shown in FIG. 7B.

[0054]FIG. 7D illustrates a cross-section at 7D-7D of the embodiment ofthe system illustrated in FIG. 7C.

[0055]FIG. 7E illustrates another embodiment of the system illustratedin FIG. 7C for implanting an implant in a body.

[0056]FIG. 7F is a side view of another embodiment of the system forimplanting an implant in a body.

[0057]FIG. 7G illustrates another embodiment of the system illustratedin FIG. 7F for implanting an implant in a body.

[0058]FIG. 8A illustrates one embodiment of a system for implanting animplant in a body.

[0059]FIG. 8B illustrates a sleeve for use in the system illustrated inFIG. 8A for implanting an implant in a body.

[0060]FIG. 8C illustrates another embodiment of the sleeve for use inthe system illustrated in FIG. 8A for implanting an implant in a body.

[0061]FIG. 8D illustrates another embodiment of the sleeve for use inthe system illustrated in FIG. 8A for implanting an implant in a body.

[0062]FIG. 8E illustrates another sleeve for use in the systemillustrated in FIG. 8A for implanting an implant in a body.

[0063]FIG. 8F illustrates making a system for implanting an implant in abody illustrated in FIG. 8A.

[0064]FIG. 8G illustrates a top view of a system for implanting animplant in a body illustrated in FIG. 8A.

[0065]FIG. 8H illustrates a side view of the system for implanting animplant in a body illustrated in FIG. 8A.

[0066]FIG. 8I illustrates another view of the system for implanting animplant in a body illustrated in FIG. 8H.

[0067]FIG. 8J illustrates another embodiment of the sleeve illustratedin FIG. 8D.

[0068]FIG. 8K illustrates another embodiment of the system forimplanting an implant in a body illustrated in FIG. 8G.

[0069]FIG. 9A illustrates another embodiment of the system forimplanting an implant in a body illustrated in FIG. 8A, where theimplant is a sling.

[0070]FIG. 9B illustrates another embodiment of the system forimplanting an implant in a body illustrated in FIG. 9A.

[0071]FIG. 9C illustrates another embodiment of the system forimplanting an implant in a body illustrated in FIG. 9A.

[0072]FIG. 9D illustrates another embodiment of the system forimplanting an implant in a body illustrated in FIG. 9A.

[0073]FIG. 9E illustrates another embodiment of the system forimplanting an implant in a body illustrated in FIG. 8G.

[0074]FIG. 10A illustrates one embodiment of a system for implanting animplant in a body.

[0075]FIG. 10B illustrates a sleeve for use in the system illustrated inFIG. 10A for implanting an implant in a body.

[0076]FIG. 10C illustrates a sleeve for use in the system illustrated inFIG. 10A for implanting an implant in a body.

[0077]FIG. 10D illustrates a sleeve for use in the system illustrated inFIG. 10A for implanting an implant in a body.

[0078]FIG. 10E illustrates a sleeve for use in the system illustrated inFIG. 10A for implanting an implant in a body.

[0079]FIG. 10F illustrates another embodiment of a system for implantingan implant in a body illustrated in FIG. 10A, where the implant is asling.

[0080]FIG. 11A illustrates an embodiment of the attachment pieceaccording to the invention.

[0081]FIG. 11B illustrates an embodiment of an implant secured to theattachment piece illustrated in FIG. 11A.

[0082]FIG. 11C illustrates a perspective view of an embodiment of animplant-delivery member such as an attachment piece for delivering animplant to a body.

[0083]FIG. 11D illustrates a side view of the embodiment of FIG. 11C.

[0084]FIG. 11E illustrates a top plan view of the embodiment of FIG.11C.

[0085]FIG. 11F illustrates a bottom plan view of the embodiment of FIG.11C.

[0086]FIG. 11G illustrates a rear view of the embodiment of FIG. 11C.

[0087]FIG. 11H illustrates a front view of the embodiment of FIG. 11C.

[0088]FIG. 11I illustrates a perspective view of another embodiment ofan implant-delivery member such as an attachment piece for delivering animplant to a body.

[0089]FIG. 11J illustrates a side view of the embodiment of FIG. 11I.

[0090]FIG. 11K illustrates a top plan view of the embodiment of FIG.11I.

[0091]FIG. 11L illustrates a bottom plan view of the embodiment of FIG.11I.

[0092]FIG. 11M illustrates a rear view of the embodiment of FIG. 11I.

[0093]FIG. 11N illustrates a front view of the embodiment of FIG. 11I.

[0094]FIG. 12A illustrates an embodiment of the dilator tube accordingto the invention.

[0095]FIG. 12B illustrates another embodiment of the dilator tubeillustrated in FIG. 12A.

[0096]FIG. 13 illustrates an embodiment of the dilator tube and cannulaaccording to the invention.

[0097] FIGS. 14-17 illustrate an embodiment of the steps according tothe method of the invention for seating and securing the attachmentpiece to the dilator tube.

[0098]FIG. 18A illustrates another embodiment of the attachment pieceaccording to the invention.

[0099]FIG. 18B illustrates assembly of the attachment piece illustratedin FIG. 18A.

[0100]FIG. 19A illustrates an embodiment of the delivery assemblyaccording to the invention.

[0101]FIG. 19B illustrates a perspective view of an embodiment of ahandle for delivering an implant to a body.

[0102]FIG. 19C illustrates a front view of the embodiment of FIG. 19B.

[0103]FIG. 19D illustrates a rear view of the embodiment of FIG. 19B.

[0104]FIG. 19E illustrates a side view of the embodiment of FIG. 19B.

[0105]FIG. 19F illustrates the opposing side view of the embodimentshown in FIG. 19E.

[0106]FIG. 19G illustrates a top plan view of the embodiment of FIG.19B.

[0107]FIG. 19H illustrates a bottom plan view of the embodiment of FIG.19B.

[0108]FIG. 20A illustrates an embodiment of the dilator tube and bushingaccording to the invention.

[0109]FIG. 20B illustrates a cross-section at 20B-20B of the embodimentof the dilator tube illustrated in FIG. 20A

[0110]FIG. 20C illustrates an embodiment of the dilator tube illustratedin FIG. 19A in an extended position from the handle.

[0111]FIG. 20D illustrates an embodiment of the dilator tube illustratedin FIG. 19A with the dilator tube in a retracted position in the lumenof the handle.

[0112]FIG. 20E illustrates an embodiment of the dilator tube illustratedin FIG. 13.

[0113]FIG. 21A illustrates an embodiment of the cannula according to theinvention.

[0114]FIG. 21B illustrates a cross-section at 21B-21B of the embodimentof the cannula illustrated in FIG. 21C.

[0115]FIG. 21C illustrates an embodiment of the cannula with the dilatortube retracted.

[0116]FIG. 22A illustrates an embodiment of the retractable pointaccording to the invention.

[0117]FIG. 22B illustrates a cross-section of the retractable pointaccording to the invention.

[0118]FIG. 22C illustrates the retractable point, illustrated in FIG.22A, extended from the cannula.

[0119]FIG. 23A illustrates two positions of an embodiment of theproximal and distal buttons and two positions of the cannula retractorbutton on the handle according to the invention.

[0120]FIG. 23B illustrates three positions of an embodiment of theproximal and distal buttons and two positions of the cannula notch andtwo positions of the cannula retractor button on the handle according tothe invention.

[0121]FIG. 23C illustrates another embodiment of the cannula notchillustrated in FIG. 23B.

[0122]FIG. 23D illustrates an embodiment of an implant with a couplingring.

[0123]FIG. 23C illustrates another embodiment of an implant with acoupling ring.

DESCRIPTION

[0124] In general, the invention described herein is a system forimplanting an implant into the body of a patient. Referring to FIG. 1A,in one aspect, the system includes an implant 10, an envelope 20enclosing the implant, an attachment piece 350 for attaching theenvelope 20 or implant 10 to a delivery assembly 650, and a deliveryassembly 650 for delivering the implant 10 to an anatomical site in thebody of a patient. In one embodiment, the delivery assembly 650 has adelivery handle 700, a dilator tube 500, and a cannula 600.

[0125] In one aspect, the invention relates to an envelope for enclosingthe implant. The envelope includes a therapeutic drug, such as anantibiotic, on the outer surface, the inner surface, or both the outerand inner surface of the envelope.

[0126] In one embodiment of the invention illustrated in FIG. 1B, thesystem includes an implant 10, for example, a surgical mesh or asurgical sling, surrounded by or enclosed within an envelope 20. Theenvelope 20 may be likened to a pouch or a sleeve that surrounds themesh 10.

[0127] Referring to FIG. 1C, in one embodiment, the envelope 20 has alumen 185, and the envelope 20 is, for example, a tube that encloses themesh 10. The envelope 20 has an inner surface 30 and an outer surface40. Referring again to FIG. 1C, the width 24 of the envelope 20, asmeasured between the first side 203 and the second side 204 of envelope20, may have a range from about 0.2 inches to 2.0 inches, preferablybetween about 0.5 inches and about 0.8 inches, and most preferably 0.6inches. The longitudinal axis 22 of the envelope 20, measured from thefirst end 201 to the second end 202 of envelope 20, ranges from about3.9 inches to about 27.6 inches, preferably between about 11.8 inchesand about 23.6 inches, most preferably 19.7 inches. In one embodiment,the first and second ends 201 and 202 are opened. Alternatively, thefirst and second ends 201 and 202 may be closed by, for example, a heatsealed bond.

[0128] In one embodiment according to the invention, the implant is asurgical mesh 10. The surgical mesh 10 may be fabricated from one ormore yarns and the yarns maybe made from one or more materials.Non-limiting materials that may be employed include polypropylene,polyesters, polyolefins, polytetrafluoroethylene, polyethylene,polyurethanes, nylons, and copolymers thereof as described in U.S. Pat.No. 6,042,592, the disclosure of which is incorporated by referenceherein. The surgical mesh 10 may be a hybrid of synthetic materials andtissues; the implant 10 may be directed to slings described in, forexample, U.S. Ser. No. 09/916,983, the entire disclosure of which isincorporated by reference herein. The surgical mesh 10 may also be madefor absorbable materials, such as, polyglycolic acid, polylactic acidand other suitable absorbable materials.

[0129] The yarn may include a plurality of filaments, alternatively, amonofilament yarn may be employed. In one embodiment, the mesh is apolypropylene monofilament tricot mesh for use in surgical applications.Within a mesh 10, each yarn may have void areas between yarn filaments.The process used to fabricate the mesh 10 may create crevices in themesh 10. Multifilament yams have multiple voids or interstitial spacesbetween the yam filaments. Mesh 10, according to the invention, may beproduced according to a variety of fabrication processes known to theskilled artisan including, but not limited to, knitting, weaving, orbraiding. Meshes fabricated using multifilament yams may have bothcrevices and interstitial voids. In one embodiment according to theinvention, the surgical mesh 10 is enclosed within the envelope 20 thatsurrounds the surgical mesh 10. The envelope 20 surrounding the mesh 10reduces the likelihood that the mesh 10 will become contaminated withforeign matter such as bacteria during the procedure placing the mesh atan anatomical site in the body of the patient.

[0130] With continued reference to FIGS. 1B and 1C, in one embodimentaccording to the invention, the implant 10 is a sling, for example, thesling 10 described in U.S. patent application entitled “Medical Slings”by Gellman et al., attorney docket number (BSC-205), co-filed with theinstant application, the entire disclosure of which is herebyincorporated by reference in its entirety.

[0131] The longitudinal axis 13 of the sling 10 may range from about 3.9inches to about 24.0 inches, or between about 15.7 inches to about 19.7inches, preferably about 17.7 inches. The width 14 of the sling 10 isbetween about 0.39 inches and about 1 inch, preferably about 0.43inches. Referring still to FIG. 1C, the thickness 15 of the sling 10ranges between about 0.0025 inch and about 0.1 inch, preferably betweenabout 0.001 inch and 0.01 inch.

[0132] Referring still to FIGS. 1B and 1C, the thickness of the materialused to make the envelope 20 may range from about 0.0001 inch to about0.01 inch, preferably 0.0003 inch thick. As shown in FIG. 1C, theenvelope has a first side 21 and a second side 23 opposite to first side21. The distance between the first side 21 and the second side 23 ofenvelope 20 ranges between about 0.0027 inches to about 0.12 inches.

[0133] The envelope 20 may be used to assist in handling the sling 10and/or to assist in adjusting the sling 10 during surgical placement.For example, the envelope 20 aides in preventing the sling 10 fromstretching or becoming misshapen due to the sling 10's handling prior toplacement of the sling 10 at the anatomical site within the body of thepatient.

[0134] In one aspect, the invention provides a system for delivering theimplant 10 having a drug delivery feature. The drug is delivered to theanatomical site in the patient's body and may be selected according tothe physician's preference. Exemplary drugs are preferably soluble inwater or other biologically inert solution, and include but are notlimited to antimicrobials and antibiotics, such as neomycin and sulfadrugs, and anti-inflammatory agents such as steroidal or non-steroidalanti-inflammatory agents. The drug is released to the patient tissuesupon contact with the tissues. Thus, the drugs that are delivered to thepatient tissue surfaces when accessing and inserting the envelope 20 areactive upon contact with the patient's tissue during implantation of theimplant.

[0135] For example, referring again to FIGS. 1B and 1C, in oneembodiment according to the invention, the drug delivery system includesthe envelope 20 that is made from one or more absorbent material suchas, for example, a sponge-like material. The envelope 20 may bepre-soaked in a solution containing a drug such as an antibiotic priorto surgical implantation of the implant 10 in a patient's body. Soakingthe envelope 20 in a solution containing the drug just prior to surgery,coats the outer surface 40 of the envelope 20 with the drug. Pre-soakingthe envelope in a solution of the drug is advantageous because theinside of the patient's body tissues are wiped with the drug-coatedenvelope 20 when the envelope 20 is inserted into the patient's bodyduring surgical implantation of the implant 10. Alternatively, the drugin the drug solution in which the envelope is soaked, penetrates theabsorbent material and coats the inner surface 30 of the absorbentenvelope 20.

[0136] In another embodiment, according to the invention, the envelope20 is made from a non-wettable material such as polypropylene,polyethylene, polyester, polytetrafluoroethylene, TYVEK®, MYLAR®, orco-polymers thereof. Polytetrafluoroethylene is suitable for use inaccordance with the present invention is available from DuPont(Wilmington, Del., under the trade designation TEFLON®). Thesenon-wettable materials do not uptake any liquids, for example, solutionsof drugs. In order to permit drugs to bond or absorb to thesenon-wettable material surfaces, the inner surface 30 and/or the outersurface 40 of the envelope 20 is pre-treated with a substance that iswettable such as, for example, a wettable coating composition. Thewettable coating composition may be a synthetic coating such as, forexample, polyvinylperilidone (PVP) or a natural coating such as, forexample, collagen. The coating may be a physically absorbent materialsuch as, for example, a cellulose sponge material. The wettable coatingcomposition may be hydrophilic, which absorbs hydrophilic drugs. In oneembodiment, the hydrophilic drug associates with the hydrophiliccoating. Alternatively, a hydrophobic drug is disposed on an envelope20, the envelope 20 including a hydrophobic coating. In someembodiments, a hydrophilic coating traps the hydrophobic drug on thesurface of the envelope.

[0137] In another embodiment according to the invention, a hydrophobiccoating may be applied to one or more surfaces of the envelope 20.Hydrophobic coatings may be used in conjunction with hydrophobic drugs.Where the association between the hydrophobic coating of the envelope 20and the drug is weak, the drug will be readily released to the tissuesurface contacted by the envelope 20. Alternatively, a strongerassociation between the coating and the drug, i.e., a stronger bondingaffinity, may provide a slower release of the drug.

[0138] In a particular embodiment according to the invention, thecoating applied to the surface of the envelope 20 may have an ioniccharge. According to this embodiment of the invention, drugs having acomplimentary charge will bond to the charged coating applied to thesurface of envelope 20 when the coating and the drug are exposed to oneanother. The strength of bonding between the drug and the coating willinfluence how readily the drug is released from the surface of theenvelope 20. Where the ionic bonding between the coating on the envelope20 and the drug is weak, the drug will release more readily. Covalentbonding between the surface coating of the envelope 20 and the drug willdiminish drug release.

[0139] In one embodiment according to the invention, shown, for examplein FIG. 2B, the inner surface 30 of the envelope 20 has an inner surfacecoating 35 and the outer surface 40 of the envelope 20 has an outersurface coating 45. The inner surface coating 35 and the outer surfacecoating 45 may be selected from synthetic and natural coatings. Thesynthetic or natural coatings may be selected from the group consistingof a hydrophilic agent, a hydrophobic agent, and a physically absorbentmaterial, for example, a cellulose sponge material.

[0140] In a particular embodiment of the invention, only one of thesurfaces of the envelope 20 is coated, for example only the innersurface 30 of envelope 20 is coated. Alternatively, in anotherembodiment, the outer surface 40 of envelope 20 is coated. The envelope20 with a coated surface may be dipped into a solution containing adrug, for example, a hydrophilic drug, just prior to surgery. The drugin solution bonds to the hydrophilic coating on envelope 20. In anotherembodiment, the hydrophilic coating and the hydrophilic drug are mixedto form a single coating. The hydrophilic coating may be disposed on theouter surface 40, the inner surface 30, or both the outer surface 40 andthe inner surface 30 of the envelope 20. In one embodiment, the envelopecontains a pre-loaded drug or drug and coating mixture. In yet anotherembodiment the envelope 20 is not coated, but when dipped into a drugsolution just prior to the surgery the drug coats the surface of theenvelope 20 and/or a sufficient amount of drug, for example, betweenabout 0.5 ml to about 3 ml, is trapped within the envelope 20.

[0141] Referring again to FIG. 2A and 2B, in one embodiment of theinvention, the inner surface coating 35 of the envelope 20 may behydrophobic. In another embodiment, the hydrophobic coating is mixedwith a drug that is also hydrophobic. Thereafter the premixedhydrophobic coating and hydrophobic drug combination mixture is disposedon the inner surface 30 of the envelope 20. FIG. 2B is a cross sectionof the embodiment of the system including an implant 10 illustrated FIG.2A. FIG. 2B illustrates that inner surface coating 35 is disposed on theinner surfaces 30 of the first side 21 and the second side 23 ofenvelope 20, in another embodiment a drug and coating combination maydispose thereon.

[0142] In an alternative embodiment (not shown), the outer surface 40 ofthe envelope 20 is coated with the hydrophobic coating and drugcombination mixture.

[0143] Hydrophilic coatings may be water soluble and suitable watersoluble hydrophilic coatings are available from Boston Scientific Corp.,Natick, Mass., under the trade designations HydroPlus and HydroPass.Hyoscymine sulfate may be used in accordance with the invention that isavailable under the trade designation CYTOSPAZ from Polymedica (Woburn,Mass.). Ketrolac tromethamine is available under the trade designationToradol from Roche Pharmaceuticals (Nutley, N.J.). Hydrophilic drugsthat may be employed in accordance with the invention include oxybutyninchloride, lidocaine, ketorolac, and hyoscymine sulfate. Suitablehydrophobic drugs include ibuprofen, ketoprofen, and diclofenac.Hydrophobic coatings that may be employed in accordance with theinvention include polytetrafluoroethylene, silicon, and Pyrelene.

[0144] In another embodiment according to the invention illustrated inFIGS. 3A and 3B, one or more apertures 50 are introduced into theenvelope 20. The apertures 50 may be for example, cuts or slits. Theapertures 50 extend through the envelope 20 and are disposed through atleast the first side 21 of the envelope 20. In another embodiment, theapertures 50 are introduced on all sides of the envelope 20. Theapertures 50 allow drug access to the inner surface 30 of envelope 20.For example, when the envelope 20 is soaked in a solution containing adrug, the drug enters the lumen 185 of the envelope 20 via the apertures50 and associates with the inner surface coating 35.

[0145] Referring still to FIGS. 3A and 3B, in another embodimentaccording to the invention, the outer surface 40 and inner surface 30 ofthe envelope 20 are coated with an ionic coating composition.Alternatively, only one of the outer surface 40 or inner surface 30 ofthe envelope 20 is coated with the ionic coating composition. When theenvelope 20 having apertures 50 is soaked in a solution containing adrug bearing a charge complementary to the charge of the ionic coatingcomposition, both the outer surface coating 45 and the inner surfacecoating 35 bond with the drug. FIG. 3B shows that in one embodiment, theinner surface 30 of the first side 21 of the envelope 20 includes aninner surface coating 35 and the first side 21 outer surface 40 includesan outer surface coating 45. Similarly, FIG. 3B also shows that thesecond side 23 of the envelope 20 inner surface 30 includes an innersurface coating 35 and the second side 23 outer surface 40 includes anouter surface coating 45.

[0146] In one embodiment of the invention illustrated in FIGS. 3A and3B, apertures 50 are present on at least the first side 21 of envelope20. In this embodiment, a drug contacts the inner surface 30 of theenvelope 20 when it flows through the apertures 50 into the lumen 185 ofenvelope 20. The drug associates with the inner surface coating 35. In aparticular embodiment, the outer surface coating 45 bonds with the drugwhen, for example, the envelope 20 is submerged in a solution containingthe drug.

[0147] The one or more apertures 50 disposed on the envelope 20 are, forexample, slits disposed through the envelope 20. The apertures 50 aredisposed in the envelope 20 to provide an opening on envelope 20 topermit drugs to enter the lumen 185 of envelope 20 and contact the innersurface 30 of the envelope 20. In one embodiment, the apertures 50 rangein size from about {fraction (1/16)} inch to about ¼ inch in greatestdimension and permit fluid exchange in and out of the lumen 185 of theenvelope 20. In one embodiment, the material used to manufacture theenvelope 20 is porous, for example, polytetrafluoroethylene orpolyethylene material and may be stretched so that the pores measureabout 1 micron or greater.

[0148] In one embodiment, the one or more apertures 50 may be disposedso as to permit a solution to flow into the lumen 185 of the envelope 20but not flow out, i.e., a one way channel. In another embodiment, theone or more apertures 50 disposed through the envelope 20 may be poresor slits. Such apertures 50 may range in size from about 1 micron toabout ¼ inch in largest dimension. A relatively large aperture 50, forexample, between about {fraction (1/16)} inch and about ¼ inch inlargest dimension enables the drug containing solution to readily enterinto and contact the inner surface 30 of the envelope 20 when theenvelope 20 is soaked in the solution containing the drug. Some of thesolution also escapes from the envelope 20. In another embodiment, theone ore more apertures 50 are too small, i.e. about 5 microns, to permitthe solution to escape from the envelope 20.

[0149] Shown in FIGS. 3A, and 3B, in another embodiment according to theinvention the envelope 20 may also include a tear feature 60. The tearfeature 60 assists the operator in opening the envelope 20 for placementof the mesh 10 enclosed by the envelope 20 inside the patient's body.The tear feature 60 may be a series of perforations through the envelope20. The series of perforations through the envelope 20 weakens theportion of the envelope 20 where the tears are disposed such that thetear feature 60 permits the operator to open the envelope 20 by applyingminimal force to the envelope 20. In a particular embodiment, the tearfeature 60 is disposed about the entire perimeter of the envelope 20.Alternatively, the tear feature 60 may be disposed along only a portionof the perimeter of the envelope 20.

[0150] In yet another embodiment of the invention, the tear feature 60perforations may double as the apertures 50 that permit the solution inwhich the envelope 20 is immersed to enter the lumen 185 of the envelope20 and to contact the inner surface 30 of the envelope 20. For example,where the tear feature 60 is a series of apertures 50 through theenvelope 20, the apertures 50 permit the drug solution to penetratethrough the envelope 20 to the lumen 185 to contact the inner surface 30of the envelope 20 when the envelope 20 is soaked in the drug solution.

[0151] Alternatively, the tear feature 60 includes a material that maybe easily torn open. Such easily torn materials include, but are notlimited to, for example, a material with a molecular orientation such asa linear low density polyethylene or linear polytetrafluoroethylene(e.g. TEFLON®). The entire envelope 20 may be manufactured from thesematerials. Alternatively, only one or more portions of the envelope 20are manufactured from such “tearable” materials and/or constructionmethods, i.e., sections comprising linear low density polyethyleneand/or a series of perforations or apertures 50 over a region of theenvelope. In another embodiment, according to the invention, the tearfeature 60 also includes an envelope 20 with tabs 188 and 198 that maybe torn away, as described in detail below in accordance with, forexample, FIGS. 8A-8K and 9A-9E. In yet another embodiment, the tearfeature 60 is a strip of material disposed about the entire perimeter ofthe width 24 of envelope 20. The strip of material may be positioned,for example, against the inner surface 30 of the envelope. This strip ofmaterial protrudes from one or more areas of the envelope 20 where itmay be accessed and torn away, unraveling at least a portion of theperimeter of envelope 20.

[0152] In yet another embodiment of the invention, the envelope is acomposite of two or more materials. Referring now to FIGS. 4A, 4B, and4C, the first side 21 of envelope 20 includes a first material and thesecond side 23 of envelope 20 includes a second material that isdifferent from the first material. FIG. 4C illustrates a side view of anenvelope 20 wherein the first side 21 includes a first material and thesecond side 23 includes a second material and the sides, 21 and 23, arealigned and coupled at a seam 27 to form envelope 20.

[0153] In one embodiment, the first material of the first side 21 ofenvelope 20 is selected from the group of tearable materials, thatincludes, for example, polypropylene, nylon, a material with a molecularorientation such as a linear low-density polyethylene or other availableflexible films. In another embodiment, the second material on the secondside 23 of envelope 20 may be a material that does not tear, forexample, polytetrafluoroethylene, TYVEK®, MYLAR® or other materials suchas, for example, thermoplastics. According to the invention, thecomposite envelope 20 may be formed of two different materials that donot tear, for example, a first side 21 having TYVEK® and a second side23 having MYLAR®. Alternatively, the composite envelope 20 may be formedof two materials that tear, such as a first side 21 of polyethylene anda second side 23 of polypropylene.

[0154]FIG. 4A illustrates a first side 21 and FIG. 4B illustrates asecond side 23 of the envelope 20 illustrated in FIG. 4C. Referringagain to FIG. 4A, width 241 of the first side 21 measured from the upperside 931 to the lower side 941, ranges from about 0.2 inches to about2.0 inches, or between about 0.5 inches and about 0.8 inches and,preferably, 0.6 inches. The longitudinal axis 221 of the first side 21,measured from the first end 911 to the second end 921, as illustrated inFIG. 4A, ranges in length from about 3.9 inches to about 27.6 inches, orbetween about 11.8 inches and about 23.6, preferably 19.7 inches.Referring again to FIG. 4B, the width 242 of the second side 23,measured from the upper side 932 to the lower side 942, ranges fromabout 0.2 inches to about 2.0 inches, or between about 0.5 inches andabout 0.8 inches, preferably, 0.6 inches. The longitudinal axis 222 ofthe second side 23, measured from the first end 912 to the second end922, ranges from about 3.9 inches to about 27.6 inches, or between about11.8 inches and about 23.6 inches preferably, 19.7 inches.

[0155] Referring again to FIGS. 4A, 4B and 4C, in one embodiment thefirst side 21 and the second side 23 of the envelope 20 may be cut tothe same dimensions and the first side 21 may be placed on top of andaligned with the second side 23. When the first side 21 and the secondside 23 are aligned, the first side 21 upper side 931 and the secondside 23 upper side 932 are adjacent (not shown), the first side 21 lowerside 941 and the second side 23 lower side 942 are adjacent, the firstside 21 first end 911 and the second side 23 first end 912 are adjacentand the first side 21 second end 921 and the second side 23 second end922 are adjacent. An envelope 20 may be formed by, for example, heatbonding around the perimeter of the aligned first side 21 and secondside 23, to form seam 27 around the four sides of the aligned first side21 and second side 23. Referring still to FIG. 4C, in anotherembodiment, to form a tubular envelope 20 a first seam (not shown) isformed between the first side 21 upper side 931 and the second side 23upper side 932 and a second seam 27 is formed between the first side 21lower side 941 and the second side 23 lower side 942, thereafter theinterior of envelope 20 includes a lumen 185 with an open first end 201and an open second end 202.

[0156] Alternatively, when the first side 21 is placed on top of thesecond side 23, the second side 23 that is adjacent to the first side 21may include a melt liner. A melt liner is a layer or a portion of alayer that when added to the first side 21 and/or the second side 23aids in forming the seam 27 between the first side 21 and the secondside 23, when, for example, the sides 21 and 23 are exposed to adesirable temperature range. Suitable melt liners that may be employedinclude, for example, low density polyethylene, polyurethane, andpolyester. In one embodiment, the second side 23 includes a materialthat cannot tear, for example, TYVEK®. In one embodiment, at least theside of the TYVEK® adjacent the first side 21 is coated with a meltliner, the melt liner enables the first side 21 and the second side 23to heat seal to form seam 27 of envelope 20. In yet another embodimentof the envelope 20 shown in FIG. 4C, the first side 21 and the secondside 23 are coupled with an adhesive to form seam 27. Suitable adhesivesinclude, for example, urethane based and polyester based (i.e.,elastomeric) adhesives. In one embodiment seam 27 forms the tearableregion of the composite envelope 20. In another embodiment, illustratedin FIGS. 4D and 4E, the second side 23 is larger in dimension than thefirst side 21. In one embodiment, the dimensions of the second side 23width 242 measures about 0.8 inches and the second side 23 longitudinalaxis 222 measure about 27.6 inches. The dimensions of the first side 21width 241 measures about 0.5 inches and the longitudinal axis 221measures about 27 inches. The first side 21 has a top side 21 a and abottom side 21 b (not shown) and the first side 21 is placed on top ofthe second side 23. In another embodiment, the first side 21 is placedin the center of the second side 23. The second side 23 has a top side23 a and a bottom side 23 b.

[0157]FIG. 4E and 4F shows that a portion of the excess material alongthe width 242 of the second side 23, shown in FIG. 4D, is folded to lieon the top side 21 a of the first side 21. The folded portion 26 of theupper side 932 of the second side 23 is coupled to the top side 21 a ofthe first side 21 to form a first seam 27, and the folded portion 26 ofthe lower side 942 of the second side 23 is also coupled to the top side21 a of the first side 21, to form a second seam 27. The folded portion26 of the second side 23 folded on the top side 21 a of the first side21 includes adhesive, which couples the second side 23 top side 23 a tothe first side 21 top side 21 a, to form an envelope 20 having a lumen185. Alternatively, the second side 23 top side 23 a, that is adjacentto the first side 21 top side 21 a, contains a melt liner. When theportion of the second side 23 is folded over the first side 21 the meltliner joins the folded portions 26 of the second side 23 to the firstside 21, by, for example, introducing heat to the folded portions 26 tobond the second side 23 to the first side 21 top side 21 a, to form theseam 27. In yet another embodiment, the first material of the first side21 and the second material of the second side 23 are coupled by heatbonding in the folded portions 26, to form a seam 27.

[0158] In a particular embodiment, referring again to FIGS. 4D and 4E,the first material of the first side 21 is tearable, i.e., a linear lowdensity polyethylene, and the second material of the second side 23 isnot tearable, for example, MYLAR®. Referring now to FIGS. 4E and 4F, thefolded portion 26 of the second side 23 top side 23 a is coupled to thefirst side 21 top side 21 a at the upper side 932, to form a first seam27, and at the lower side 942 of the second side 23, to form a secondseam 27. Once the first and second seams 27 are formed, the first side21 and the second side 23 form envelope 20, the envelope 20 having alumen 185. When the first end 911 of the first side 21 of the lumen 185is pulled toward the second end 921, the tearable material of the firstside 21 coupled at about the upper side 932 and the lower side 942 ofthe second side 23 at folded portions 26, is torn at the seams 27 andseparated from the second side 23. Thus, the tearable region may includethe area of the envelope where a material that does not tear is coupledto a material that does tear.

[0159]FIG.4G illustrates an embodiment where the first side 21 bottomside 21 b is coupled to the second side 23 bottom side 23 b at about thefolded portions 26 to form a first seam 27 and a second seam 27 ofenvelope 20. In an embodiment where the first material on the first side21 is not tearable and the second material on the second side 23 istearable, the second side 23 tears at the seams 27 when the first side21 is separated from the second side 23.

[0160] In another aspect, referring now to FIGS. 5A-5E, the inventionfeatures an envelope 20 having a spacer 100, the envelope 20 enclosingthe implant 10. The spacer 100 is a protrusion on at least one externalsurface of the envelope 20, having one or more pre-selected dimensionsto aid in positioning the implant 10 at an anatomical site in the bodyof a patient. In one embodiment illustrated in FIG. 5A, the envelope 20encloses an implant 10 such as a mid-urethral sling 10. The spacer 100is used to adjust the placement of the sling 10 inside the patient'sbody. For example, where the sling 10 is employed to treat stressurinary incontinence by anchorless mid-urethral sling stabilizationmethods, the spacer 100 having pre-selected dimensions, is used toprovide a reference distance between the envelope 20, which encloses thesling 10 and the patient's urethra 999. The operator is able toreference the relative distance between the envelope 20 surrounding thesling 10 and the patient's urethra 999 by the known pre-selecteddimensions of the spacer 100. The operator may also adjust the sling 10relative to the tension that is applied to the spacer 100. In oneembodiment, an envelope 20 including a tear feature 60, such asdescribed in relation to FIGS. 3A-3B, also has a spacer 100, the spacermay provide tension adjustment. The tear feature 60 simplifies removalof the envelope 20 after the sling 10 is positioned.

[0161] In one embodiment according to the invention, the spacer 100illustrated in FIG. 5A is fastened around the perimeter of envelope 20.In one embodiment, illustrated in FIGS. 5B and 5C, the spacer 100 is aclamp 110 that may be fastened around the envelope 20. The clamp 110spacer 100 may be releasably coupled to the envelope 20. The clamp 110has a first member 120 and a second member 130. The first member 120 hasa proximal end 120 a and a distal end 120 b, and at least a firstexterior face 121 extending therebetween and a first thickness 105. Theclamp 110 also has a first interior face 122. The second member 130 hasa proximal end 130 a and a distal end 130 b, and at least a secondexterior face 131 extending therebetween and a second thickness 106. Inone embodiment, (not shown), the proximal end 120 a of the first member120 and the proximal end 130 a of the second member 130 are engageablesuch as by coupling, and the distal end 120 b of the first member 120and the distal end 130 b of the second member 130 are engageable bycoupling.

[0162] In a particular embodiment, shown in FIGS. 5B and 5C, the clamp110 further includes a hinge 140. Hinge 140 of clamp 110 joins the firstmember 120 and the second member 130 of clamp 110. The proximal end 120a of first member 120 and the proximal end 130 a of second member 130couple by coupling mechanisms such as a tongue and groove, peg and hole,or other mechanisms for coupling known to the skilled person. The clamp110 is sized to encircle the envelope 20. The length of the firstinterior face 122 of the first member 120 of clamp 110 and the length ofthe second interior face 132 of the second member 130 of clamp 110ranges from about 0.2 inches to 2.0 inches. The dimensions of interiorface 122 of clamp 110 and interior face 132 of clamp 110, are selectedin accordance with the dimensions of the envelope 20.

[0163] Referring now to FIG. 5D, the width 125 of the first member 120and the width of the second member 130 of the clamp 110 (not shown) mayrange between about 0.2 inches and about 0.8 inches, preferably betweenabout 0.4 inches and about 0.6 inches. The length 127 of the firstmember 120 of the clamp 110 may range from about 0.2 inches to 2.0inches. Referring again to FIGS. 5B and 5C, the thickness 105 of thefirst member 120 of clamp 110 may range between about 0.007 inches andabout 0.12 inches.

[0164] In one embodiment, referring still to FIGS. 5A and 5B, the spacer100 includes the first member 120. The thickness 105 of the first member120 of spacer 100 establishes the distance between the envelope 20enclosing the sling 10 and the patients urethra 999 or the patientsbladderneck. Where the first member 120 is the spacer, the thickness 105of spacer 100 may measure between about 0.007 inches and about 0.8inches, preferably between about 0.2 inches to about 0.6 inches. In anembodiment where the spacer 100 is placed adjacent the patients urethra999, the length of the first member 120, measured by the distancebetween the proximal 120 a and distal ends 120 b of the first member120, may be sized to complement the length of the patients urethra 999,generally between about 0.2 inches and 1.2 inches.

[0165] As shown in the embodiment illustrated in FIG. 5E, the spacer 100may include a bulk material 112 disposed on the first side 21 of theenvelope 20. The bulk material 112 may be, for example, polyethylene ora hydrogel, such as, sodium carboxymethylcellulose, phosphate bufferedsaline (PBS), or combinations thereof. In one embodiment, the bulkmaterial 112 may be disposed on the entire surface of the first side 21of envelope 20.

[0166] Alternatively, as shown in FIG. 5E, the bulk material 112 may bedisposed on only a portion of the first side 21 of envelope 20. Forexample, in one embodiment, the bulk material 112 is disposed at themidpoint between the first end 201 and the second end 202 of thelongitudinal axis of the first side 21 of envelope 20. The bulk material112 may be disposed between about 0.1 inches to about 0.4 inches,preferably between about 0.2 inches to about 0.3 inches to each side ofthe midpoint of the longitudinal axis. With continued reference to FIG.5E, the bulk material 112 of the spacer 100 may be disposed across thewidth 24 of the first side 21 of the envelope 20, i.e., between the topside 203 and the bottom side 204 of the envelope 20. Referring again toFIG. 5A, when the envelope 20 enclosing the sling 10 is employed totreat stress urinary incontinence by anchorless mid-urethral slingstabilization methods, the width 24 of the envelope 20 is adjacent theurethra 999 or the bladderneck. A spacer 100 provides a referencedistance between the envelope 20 and the patient's urethra 999 or thepatient's bladderneck. The bulk material 112 should be disposed aboutbetween about 0.2 inches to about 1.2 inches along the width 24 ofenvelope 20, because the spacer 100 should be equal to or smaller thanthe length of the female urethra, and generally, the maximum length ofthe female urethra is 1.2 inches. The thickness 103 of the bulk material112 disposed on the first side 21 may range from about 0.007 inches toabout 0.8 inches, preferably between about 0.2 inches to about 0.6inches.

[0167] In yet another embodiment, illustrated in FIGS. 5F-5G, the spacer100 includes a balloon 111. In one embodiment, the balloon 111 is partof and integral with the envelope 20. In another embodiment, the spacer100, balloon 111, is joined to the envelope, for example, by adhesives.

[0168] In one embodiment, the balloon 111 is positioned on the innersurface 30 of the first side 21 of envelope 20. In another embodiment,the balloon 111 is positioned on the outer surface 40 of the first sideof envelope 20. The balloon 111 may be disposed along the entire lengthof the first side 21 of envelope 20. Alternatively, as shown in FIGS.5F-5G, the balloon 111 may be disposed on only a portion of the firstside 21 of envelope 20. For example, in one embodiment, the longitudinalaxis 107 of balloon 111 is between about 1.2 inches to about 4.0 inchesabout the midpoint of the longitudinal axis 22 of the envelope 20. Thewidth 104 of the balloon 111 measures between about 0.4 inches to about1.2 inches. In a particular embodiment, the longitudinal axis 107 ofballoon 111 is between about 0.2 inches to about 0.8 inches, preferablybetween about 0.4 inches and 0.6 inches, about the midpoint of thelongitudinal axis 22 of the envelope 20, and the width 104 of theballoon 111 is between about 0.4 inches to about 1.2 inches. In oneembodiment, the width 104 of balloon 111 is equal to or smaller than thelength of the female urethra, generally equal to or less than 1.2inches. In another embodiment, the width 104 of the balloon 111 is thesame as the width 24 of the envelope 20.

[0169] The balloon 111 may be made from the same materials as theenvelope 20. These materials include, but are not limited to, forexample, an absorbent material, such as a sponge-like material, orpolypropylene, polyethylene, polyester, polytetrafluoroethylene orcopolymers thereof. Alternatively, the balloon 111 may be made of adifferent material than the material used to make the envelope 20. Theballoon 111 may be placed on the envelope 20 according to methods knownto the skilled person, for example, by gluing, sewing, tying, or meltingonto a surface of envelope 20. In one embodiment, the balloon 111 isfilled with a fluid or a gas and then joined to the exterior surface 40of the first side 21 of the envelope 20. Alternatively, the balloon 111may be filled with a gas or liquid after the balloon 111 is joined tothe envelope 20. In yet another embodiment, the balloon 111 is integralwith, i.e., fabricated in the envelope 20 when the envelope 20 isfabricated.

[0170] The balloon 111 may be filled with a gas or a fluid, for example,water, sterilized water, saline, or a bulk material such as, forexample, polyethylene or a hydrogel, such as, sodiumcarboxymethylcellulose, PBS phosphate buffered saline, or combinationsthereof. In another embodiment, the balloon 111 may be filled to athickness 103 between about 0.08 inches to about 0.8 inches, preferablyabout 0.2 inches to about 0.6 inches. The extent of inflation of theballoon 111 may vary according to operator preference, the size of thepatient, the anatomical location where the balloon is positioned, orother factors. In one embodiment, the balloon 111 is filled by theoperator prior to commencing the surgical procedure. Alternatively, theballoon 111 is filled after the envelope 20 enclosing the implant 10 isintroduced into the anatomical site of the patient's body.

[0171] In one embodiment, according to the invention, the balloon 111may be filled by inserting a needle coupled to a syringe into theballoon 111 and injecting the contents of the syringe, e.g., air, water,sterilized water, saline, bulk material, or a combination thereof, intothe balloon 111. Alternatively, the balloon 111 may include a valve andthe balloon is subsequently filled by injecting the contents of thesyringe into the balloon 111. In one embodiment, the balloon 111 ispre-filled and pre-attached to envelope 20.

[0172] In another embodiment, shown in FIGS. 5H and 5I, the clamp 110includes a balloon 111 or a bulk material 112. For example, shown inFIG. 5H, the first exterior face 121 of the first member 120 includes aballoon 111. In this embodiment, the thickness of spacer 100 includes acombination of the thickness 105 of the first member 120 and thethickness 103 of the balloon, bulk material, or other spacer device. Thethickness of the spacer 100 includes the first member 120 thickness 105and the balloon 111 thickness 103 or the first member 120 thickness 105and the bulk material 112 thickness 103, respectively, as shown in FIGS.5H and 5I. The spacer 100 thickness measures between about 0.007 inchesto about 0.8 inches, preferably between 0.08 inches and 0.7 inches,preferably between about 0.2 inches to about 0.6 inches.

[0173] Referring to FIG. 5H, the balloon 111 may be disposed on thefirst exterior face 121 of the first member. Similarly, as shown in FIG.5I the bulk material 112 may be disposed on the first exterior face 121of the first member 120. In one embodiment, the balloon or bulk materialentirely covers the first member 120 first exterior face 121. Referringagain to FIG. 5A, where the spacer 100 is employed in mid-urethral slingprocedures, the spacer 100 is positioned adjacent to the urethra 999 orbladdemeck. The urethra length is generally up to 3 cm, about 1.2inches. Thus, where the balloon or the bulk material together with thefirst member 120 of the clamp 110 form the spacer 100, the length of thespacer 100 will be sized accordingly. Referring again to FIG. 5D, theballoon or the bulk material are positioned to cover between about 0.2inches and about 1.2 inches of the length 127 of the first member 120 toform spacer 100. In one embodiment, the balloon 111 and the bulkmaterial 112 are positioned to cover between about 0.2 inch and about0.8 inch of the width 125 of first member 120. In a particularembodiment, the balloon 111 or the bulk material 112 covers the width125 of the first member 120.

[0174] In another embodiment, the clamp 110 includes a pressuresensitive mechanism, i.e., a pressure sensor 101. In one embodiment,illustrated in FIG. 5B, the clamp 110 includes the pressure sensor 101on the exterior face 121 of the first member 120. In another embodiment,as shown in FIG. 5H, the first exterior face 121 of the first member 120includes the spacer 100, such as, a balloon 111, and the pressure sensor101. The pressure sensor 101 indicates the pressure applied to thespacer 100. Alternatively, the spacer 100 disposed on envelope 20 asshown in FIG. 5G includes the pressure sensor 101.

[0175] Referring again to FIGS. 5A and 5B, the pressure sensor 101 isemployed during the surgical procedure to measure and/or indicate thepressure applied to the urethra 999 or bladderneck by the spacer 100.The spacer 100 is adjacent (i.e., disposed on or joined to) the envelope20 enclosing the implant 10. When implanting the envelope 20 enclosingthe sling 10, tension is applied to the envelope 20 to adjust thedistance between the urethra 999 or bladderneck and the sling 10. Atarget pressure range may be set in the pressure indicator or pressuregauge. The pressure sensor 101 may be, for example, a tube that isconnected at one end of the tube to the spacer 100 and at the other endof the tube to a pressure indicator. When the appropriate level oftension is applied to the spacer 100, the pressure sensor 101 indicatesthat the targeted pressure range is achieved. The pressure sensor 101may indicate that this pressure is achieved by various indicator means,such as, for example, sound, digital readout, mechanical indicators, andfluid displacement (i.e., a manometer). When the pressure sensor 101indicates the pressure range has been met and the envelope 20 placementis properly adjusted, then the spacer 100 and the envelope 20 areremoved leaving the sling 10 correctly positioned and at the appropriatetension at the anatomical site in the patient's body. In anotherembodiment, after the spacer 100 and envelope 20 are removed, a gapcreated by the spacer 100 is left between the sling 10 and the urethra999 and there is no load present between the sling 10 and the urethra999. In an embodiment where the spacer 100 is a clamp 110 fastenedaround the permimeter of envelope 20, the clamp 110 is released fromenvelope 20 prior to removing the envelope 20 from the anatomical sitein the patient's body.

[0176] In another embodiment according to the invention the envelope 20and/or the clamp 110 are tinted. In one embodiment, only a portion ofthe envelope 20 is tinted, for example, about the longitudinal axis 22of envelope 20. The envelope 20 and the clamp 110 may be the same coloror alternatively, they may be tinted differently. In yet anotherembodiment, a pattern or design is applied to on the envelope 20 and/orthe clamp 110. In a preferred embodiment, the envelope 20 is tinted bluewhich is visible under the light from a cytoscope that is used whenimplanting the sling 10 into the body of the patient. In anotherembodiment, the envelope 20 is tinted black. In yet another embodiment,a spacer, a clamp, a tinted area or other indication mark provides avisual indication of the placement of the sling 10. The visualindication may be employed to inform the operator about the orientationof the sling 10, for example, whether the sling 10 is facing up, facingdown or is twisted. In one preferred embodiment, the visual indicationmark is on the center of the envelope 20 enclosing the sling 10. In onepreferred procedure, with continued reference to FIG. 5A, a visualindication of clamp 110 is aligned with the urethra 999.

[0177] In yet another embodiment, as shown, for example, in FIG. 6, theenvelope including a balloon 111 includes an outer surface coating 45 onthe outer surface 40 of the envelope 20. A therapeutic drug may beassociated such as, for example, bonded with the outer surface coating45. The envelope 20 with the spacer 100 may further include one or moredrugs and/or one or more coatings as described above (see FIGS. 1A, 1B,2A, 2B, 3A, and 3B and corresponding text).

[0178] In another aspect, the invention is a system for delivering animplant enclosed in an envelope. In one embodiment, according to theinvention, the envelope 20 has two or more sleeves 20A, 20B that arepositioned such that one end of the first sleeve 20A overlaps anadjacent end of the second sleeve 20B. The two sleeves 20A, 20B enclosethe implant 10. For example, referring to FIG. 7A, first sleeve 20A hasa proximal end 154 including a tab 158 and a distal end 150. In oneembodiment, the tab 158 seals the proximal end 154 of the first sleeve20A. In another embodiment, the tab 158 is a positioning member forpositioning the envelope 20 at the anatomical site in the body of thepatient. Referring still to FIG. 7A, the distal end 150 of first sleeve20A is adjacent to the proximal end 160 of second sleeve 20B. The distalend 164 of second sleeve 20B includes a tab 168. In one embodiment, tab168 seals the distal end 164 of second sleeve 20B. In anotherembodiment, the tab 168 is a positioning member for positioning theenvelope 20 at the anatomical site in the body of the patient.

[0179] The length of first sleeve 20A, measured from the distal end 150to the proximal end 154, may range from about 2.0 inches to about 15.4inches, preferably 11.0 inches. The length of second sleeve 20B,measured from the proximal end 160 to the distal end 164, may range fromabout 2.0 inches to about 15.4 inches, preferably 11.0 inches. In oneembodiment, the first and second sleeves 20A and 20B, are of equallength from their distal end to proximal end. FIG. 7B shows an implant10, for example, a mid-urethral sling, a portion of which is placed intothe distal end 150 of first sleeve 20A and a portion of which is placedinto the proximal end 160 of second sleeve 20B. The length of the sling10, i.e., the distance from the proximal end 11 to the distal end 12 ofthe sling 10, may range from about 4.0 inches to about 24.0 inches, orbetween about 16.0 inches to about 20.0 inches, preferably about 18.0inches.

[0180]FIG. 7C shows one embodiment of the envelope 20 including firstsleeve 20A and second sleeve 20B enclosing the implant 10. As shown in7C, the proximal end 160 of sleeve 20B is inserted into the distal end150 of sleeve 20A to form an overlap region 20C of the first and secondsleeves 20A, 20B. The overlap region 20C of first sleeve 20A and secondsleeve 20B may range in length from about 0.4 inches to about 3.2inches, preferably between 0.8 inches and 1.6 inches. FIG. 7Dillustrates one embodiment of a cross section of region 20C of theenvelope 20 where the proximal end 160 of second sleeve 20B is enclosedby the distal end 150 of first sleeve 20A. Referring again to FIG. 7C,the length of the overlap region 20C, the length of the sling 10, andthe length of first sleeve 20A and second sleeve 20B are selected toprovide a section 172 of the sleeve 20A, from the proximal end 11 of thesling 10 to the proximal end of the 154 of sleeve 20A, that is at least1 inch in length. Similarly, the section 174 of the sleeve 20B, from thedistal end 12 of sling 10 to the distal end 164 of sleeve 20B, is atleast 1 inch in length. The sections 172 and 174 are grasped by theoperator and assist in removal of the envelope 20 from the patient'sbody without disturbing the position of the implant of sling 10, asdescribed below.

[0181] The longitudinal axis 22 of the envelope 20, measured between thefirst side 201 and the second side 202, ranges from about 3.6 inches toabout 30.4 inches, or between about 11.8 inches and about 23.6 inches inlength, preferably 19.7 inches. The width 24 of the envelope 20 measuredbetween the top side 203 and the bottom side 204 of envelope 20 mayrange from about 0.2 inches to about 2.0 inches, or between about 0.5inches and about 0.8 inches, preferably 0.6 inches.

[0182] In another embodiment according to the invention illustrated inFIGS. 7E, 7F, and 7G, the clamp 110 is used to fasten the sleeves 20Aand 20B in the overlap region 20C such that the sleeves 20A and 20B aresecured in place and the implant 10 remains inside the envelope 20. Inthis embodiment, the clamp 110 is positioned and secured about theperimeter of the overlap region 20C of envelope 20. As shown in FIGS. 7Eand 7F, the first member 120 and the second member 130 of clamp 110 areclosely aligned and positioned to provide enough compressive force tosecure the region 20C and prevent separation of first sleeve 20A andsecond sleeve 20B during a procedure in which the envelope 20 ispositioned at the anatomical site in the patient's body. In oneembodiment, the clamp 110 or other fastener releasably couples sleeves20A and 20B and after the envelope 20 including clamp 110 is positionedin the patient's body, the clamp 110 is unfastened and removed.Thereafter sleeves 20A and 20B are removed and sling 10 remainspositioned at the anatomical site in the patient's body. Alternativefasteners, not shown, may be employed to secure the implant inside thesleeves of the envelope such as, for example, hemostats, needlegraspers, and spring loaded clamps.

[0183]FIG. 7F shows a sideview of the envelope 20 illustrated in FIG.7E. The envelope 20 includes two sleeves 20A and 20B and a clamp 110.The clamp 110 is employed to couple the sleeves 20A and 20B, enclosingthe implant 10. As shown in FIG. 7F, the proximal end 160 of sleeve 20Binside the distal end 150 of sleeve 20A forms overlap region 20C. Theclamp 110 is placed around the perimeter of the overlap region 20C. Inthis view, a hinge 140 of clamp 110 is visible from the side view of theenvelope 20.

[0184] In another aspect, the invention includes a method forpositioning the sling 10 at an anatomical site in a patient's body, forexample, positioning a mid-urethral sling for the treatment of femaleurinary incontinence. In one embodiment of the method according to theinvention, the clamp 110 is placed at about the mid point of the sling10, for example, as illustrated in FIGS. 7E and 7F. The physician mayuse the clamp 110 to indicate placement of the envelope enclosing thesling 10. During placement of the sling 10, the clamp 110 is positioneddirectly under the patient's urethra 999. The clamp 110 may furtherinclude the spacer 100. As described above, in relation to, for example,FIGS. 5H and 5I, the spacer 100 may include the thickness 105 of thefirst member 120 of clamp 110, alternatively or in addition, thethickness of the spacer 100 on the clamp 110 may include the thickness103 of a balloon 111 or the thickness 103 of the bulk material 112. Theoperator may use the spacer 100 to adjust the tension of the sling 10during its placement. In another embodiment, the clamp 110 furtherincludes a pressure sensor, for example, the pressure sensors 101described above in conjunction with FIGS. 5B, 5F, 5G and 5H. Thepressure sensor 101 is used by the operator to aid in positioning thesling 10 and applying the proper tension to the sling 10.

[0185] In one embodiment of the method according to the invention, theoperator positions the envelope 20, shown in FIGS. 7E and 7F, includingfirst sleeve 20A, and second sleeve 20B, the sling 10, and the clamp110, at the anatomical site in the body of the patient. In oneembodiment according to the invention, when the operator is satisfiedwith the position and/or tension of the sling 10, clamp 110 may beuncoupled, released from the envelope 20, and removed from the body ofthe patient. Thereafter, the operator may remove second sleeve 20B andfirst sleeve 20A from the body of the patient by grasping and pullingsleeve sections 174 and 172, respectively. The removal of the clamp 110and sleeves 20A and 20B are completed with care to maintain the sling 10placement and tension and to avoid stretching the sling 10 material.Thus, according to a particular embodiment of the invention, the removalof first sleeve 20A and second sleeve 20B causes no change in sling 10position. Thus, the placement and/or tension of the sling 10 remains thesame as the placement and tension of the sling 10 when the operatorplaced the sling 10 at the anatomical site in the body, prior to removalof first sleeve 20A and second sleeve 20B.

[0186] In yet another embodiment according to the invention, theenvelope 20 including first sleeve 20A, second sleeve 20B, the sling 10,and the clamp 110, shown in FIG. 7G also includes an outer surfacecoating 45 disposed on the outer surface of envelope 20. The envelope 20including sleeves 20A, 20B and the clamp 110, may further include one ormore drugs and/or one or more coatings as described above (see FIGS. 1A,1B, 2A, 2B, 3A, and 3B and corresponding text).

[0187] In another aspect, the invention includes a system for deliveringan envelope and an implant. In one embodiment, shown in FIG. 8A, thesystem includes the envelope 20 including two or more sleeves 20A, 20Band one or more tabs 188, 198, 208, 218. The tabs 188, 198, 208, and 218simplify placement and/or removal of the envelope 20 from inside thebody of the patient.

[0188] Referring to FIG. 8A, in one embodiment according to theinvention, the system includes an envelope 20 including the first sleeve20A, the second sleeve 20B, tabs 188, 198 and an envelope hinge 200. Theenvelope 20 encloses the implant 10. For example, FIG. 8B illustratesthe first sleeve 20A of the envelope 20 shown in FIG. 8A. The firstsleeve 20A includes an inner surface 30, an outer surface 40, a proximalend 154, and a distal end 150. The first sleeve 20A has a first lumen185A. The length of the first sleeve 20A between the proximal end 154and the distal end 150, along the longitudinal axis 22A, is betweenabout 4.0 inches and about 28.0 inches, preferably about 20.0 inches.The perpendicular axis 24A of first sleeve 20A measures between about0.2 inches to about 2.0 inches, preferably between about 0.4 inches andabout 0.8 inches, preferably about 0.6 inches.

[0189] Referring still to FIG. 8B, in an embodiment of the invention,two angles are cut into the first sleeve 20A, as indicated by the arrow172 and arrow 174. The angles 172 and 174 are cut in the range of fromabout 20° to about 100°, or about 30° to about 70°, preferably about60°, from the longitudinal axis 22A of the sleeve 20A illustrated inFIG. 8B. In one embodiment, the two angles 172 and 174 are cut into thefirst sleeve 20A at a distance of between about 0.01 inch and about 0.05inch, preferably about 0.04 inch. In one embodiment, the distance cutinto the first sleeve 20A is equivalent to the thickness of the sleeve20A material. The angles 172 and 174 and the placement therefor maysimplify tearing the envelope 20 with the tab 188, as described below,by, for example, providing a starting point for the tear. The distal end150 portion of sleeve 20A is trimmed along the longitudinal axis 22Afrom the distal end 150 to angle 172 and from the distal end 150 to theangle 174. In general, the amount of the first sleeve 20A that istrimmed along the longitudinal axis 22A from the distal end 150 to eachrespective angle is substantially the same. Because the first sleeve 20Ahas a first lumen 185A, and its structure is tube-like, after the firstsleeve 20A is trimmed, the distal end 150 portion has a top section 150Aand a bottom section 150B as illustrated in FIGS. 8C and 8D. Thelongitudinal axis 22A of first sleeve 20A from the angle 174 to the end150 of top section 150A, may measure between about 2.0 inches to about14.0 inches, preferably about 10.0 inches. The width of top section 150Ais sized so that it is equal to or smaller then the inner diameter of afirst lumen 185A of the first sleeve 20A of envelope 20. For example,the width of top section 150A may measure between about 0.1 inches andabout 2.0 inches.

[0190] Referring still to FIG. 8C, a tab 188 may be joined to the end oftop section 150A. The tab 188 may be shaped to complement the width ofthe end 150 of top section 150A. Tab 188 may include, for example,adhesive that is adhered to the end 150 of the top section 150A. Inanother embodiment, the tab 188 may include a paperboard that is joinedto the top section 150A by an adhesive, staple, heat bonding or othermeans known to the skilled person. It is contemplated that tab 188 mayinclude various medical grade materials that may be joined to the topsection 150A of first sleeve 20A, such as, for example TYVEK®.Alternatively, the end 150 of top section 150A may be shaped into a tab188. In this embodiment, the tab 188 may have a texture embossed on thematerial of sleeve 20A or 20B, or an additional layer of the sleeve 20Aor 20B material may be joined to the end 150 to form tab 188. In oneembodiment, the additional layer may be tinted.

[0191] As shown in FIG. 8D, in one embodiment the top section 150A,coupled to tab 188, is pulled into a first lumen 185A of first sleeve20A toward the proximal end 154 of first sleeve 20A. Accordingly, toensure that the envelope can lay flat, the width of top section 150A ispreferably sized so that is equal to or smaller then the inner diameterof the first lumen 185A, so that sleeve 20A lays flat when the topsection 150A is pulled inside the first lumen 185A.

[0192] In a particular embodiment, the top section 150A is not fullypulled into the sleeve 20A, such that an overlap region 150C of the topsection 150A remains on the outer surface 40 of the first sleeve 20A.The overlap region 150C ranges between about 0.04 inches to about 1.2inches, preferably about 0.3 inches. The length of the bottom section150B, measured from the angle 172 and the angle 174 along thelongitudinal axis 22A to the distal end 150 of the bottom section 150B,may measure between about 2.0 inches to about 14.0 inches, preferablyabout 10.0 inches.

[0193]FIG. 8E illustrates the second sleeve 20B of the envelope 20 shownin FIG. 8A. The second sleeve 20B has an inner surface 30, an outersurface 40, a proximal end 160, and a distal end 164. The second sleeve20B includes a second lumen 185B. The length of the second sleeve 20Bbetween the proximal end 160 and the distal end 164, along thelongitudinal axis 22B, is between about 4.0 inches and about 28.0inches, preferably about 20.0 inches. The perpendicular axis 24B ofsecond sleeve 20B measures between about 0.2 inches to about 2.0 inches,preferably between about 0.4 inches and about 0.8 inches, preferablyabout 0.6 inches.

[0194] Still referring to FIG. 8E, two angles represented by the arrow172 and the arrow 174, are cut into the second sleeve 20B at the rangeof from about 20° to about 100°, or about 30° to about 70°, preferablyabout 60°, from the longitudinal axis 22B of second sleeve 20B. In oneembodiment, the two angles 172 and 174 are cut into the second sleeve20B at a distance of between about 0.01 inch and about 0.05 inch,preferably about 0.04 inch. The second sleeve 20B is trimmed along thelongitudinal axis 22B from the proximal end 160 to the angle 172 andfrom the proximal end 160 to the angle 174. In general, the amount ofthe second sleeve 20B that is trimmed along the longitudinal axis 22Bfrom the proximal end 160 to each respective angle, 172 and 174, issubstantially the same. The second sleeve 20B second lumen 185B includesa tube-like structure. After the tube-like second sleeve 20B is trimmed,the proximal end 160 includes a top section 160A and a bottom section160B, as illustrated in FIG. 8E. The longitudinal axis 22B of secondsleeve 20B from the angle 172 and the angle 174 to the end of topsection 160B may measure between about 2.0 inches to about 14.0 inches,preferably about 10.0 inches. The width of top section 160A ispreferably sized so that is equal to or smaller then the inner diameterof the second lumen 185B, so that sleeve 20B lays flat when the topsection 160A is pulled inside the second lumen 185B. The width of topsection 160A may measure between about 0.1 inch and about 2.0 inches.

[0195] Referring still to FIG. 8E, a tab 198 is coupled to the end oftop section 160A. The tab 198 may be shaped to complement the width ofthe end 160 of top section 160A and tab 198 may be constructed asdescribed above with reference to tab 188. Top section 160A, coupled totab 198, is pulled into the second lumen 185B of second sleeve 20Btoward the distal end 164 of sleeve 20B. In a particular embodiment, thetop section 160A is not fully pulled into the second sleeve 20B, suchthat an overlap region 160C of top section 160A remains on the outersurface 40 of the second sleeve 20B. The overlap region 160C rangesbetween about 0.04 inches to about 1.2 inches, preferably about 0.3inches. The length of bottom section 160B, measured from the angle 172and the angle 174 along the longitudinal axis 22B to the proximal end160 of the bottom section 160B may measure between about 2.0 inches toabout 14.0 inches, preferably about 10.0 inches.

[0196] As shown in FIGS. 8F and 8G, the bottom section 150B of the firstsleeve 20A is placed at about a 90° angle relative to the longitudinalaxis 22A of the first sleeve 20A. Similarly, the bottom section 160B ofthe second sleeve 20B is placed at about a 90° angle relative tolongitudinal axis 22B of the second sleeve 20B. The sleeves 20A and 20Bare aligned in proximity to one another such that the bottom sections150B and 160B of sleeves 20A and 20B, respectively, face one another.

[0197] Referring now to FIGS. 8H and 8I, the bottom sections 150B and160B are joined to one another by adhesive, staples, heat bonding orother means known to the skilled person to form hinge 200. As shown inFIGS. 8F and 8G, the proximal end 154 of first sleeve 20A and the distalend 164 of the second sleeve 20B are positioned on opposite ends of theenvelope 20 formed by sleeve 20A and sleeve 20B. Referring again toFIGS. 8H and 81, the bottom sections 150B and 160B of sleeve 20A andsleeve 20B form the hinge 200 of the envelope 20. The envelope 20 has aproximal end 154 and a distal end 164, formed by the proximal end 154and distal end 164 of sleeve 20A and 20B, respectively. Referring againto FIG. 8G, the length of envelope 20, measured along the longitudinalaxis 22 from proximal end 154, which is equivalent to the first end 201,to distal end 164, which is equivalent to the second end 202, rangesbetween about 4.0 inches to about 28.0 inches, or between about 12.0inches and about 24.0 inches, most preferably 20.0 inches.

[0198] Referring to FIGS. 8G-8I, the overlap region 160C of sleeve 20Bof envelope 20 may lay on top of the overlap region 150C of sleeve 20Aof envelope 20. The length of overlap region 160C that is adjacent theremaining tube-like portion of the first sleeve 20A, i.e., 160C′, mayrange between about 0.02 inches to about 0.06 inches, preferably 0.04inches. Referring again to FIG. 8A, the overlap regions protect theimplant 10 inside of envelope 20, the envelope 20 including sleeves 20Aand 20B. For example, in embodiments where the envelope 20 is employedto implant a mid-urethral sling, the overlap regions 150C and 160C ofthe envelope 20 prevents sling stretching caused by, for example, ahemostat used in the surgery.

[0199] In another embodiment, illustrated in FIG. 8J, the anglesrepresented by the arrow 212 and the arrow 214, are cut into theproximal end 154 of first sleeve 20A, and sleeve 20A is trimmedsubstantially as illustrated to form a narrow portion at the end ofsleeve 20A. After the tube-like proximal end 154 of sleeve 20A istrimmed, the proximal end 154 has a top section 154A and a bottomsection 154B (not shown). The top section 154A and the bottom section154B are separated from one another. The longitudinal axis of firstsleeve 20A from the angle 212 to the proximal end 154 of top section154A, may measure between about 0.6 inches to about 4.0 inches,preferably between about 1.2 inches and about 2.0 inches. Theperpendicular axis of top section 154A may measure between about 0.1inch and about 2.0 inches. In a preferred embodiment, the perpendicularaxis of top section 154A is equal to the width of the top section 150Aof sleeve 20A, this enables the top section 150A to easily tear apartfrom the envelope. Referring to FIGS. 8J and 8K, when the proximal end154 is trimmed forming the proximal top section 154A and the proximalbottom section 154B (not shown), pulling the top section 150A coupled totab 188 through the first lumen 185A of first sleeve 20A toward theproximal end 154 is simplified. The opening between the sections 154Aand 154B simplify accessing tab 188 to pull it and top section 150Athrough first sleeve 20A toward the proximal end 154. In someembodiments, the tab 188 is pulled in between the sections 154A and154B. Thereafter, as shown in FIG. 8J, in one embodiment, a tab 208 maybe used to join the proximal top section 154A and the proximal bottomsection 154B. The tab 208 may include adhesive tape, glued paperboard,or other materials, as described above with reference to tab 188, thatare capable of coupling together the top and bottom sections, 154A and154B respectively. In one embodiment, after tab 208 joins the proximaltop and bottom sections, at about end 154 and an opening still remainsin the sleeve 20A between the top and bottom sections 154A and 154B. Thetab 188 may be accessed and pulled through this opening, while the tab208 remains at the end 154 of sleeve 20A.

[0200] Similarly, referring to FIG. 8K, the distal end 164 of sleeve 20Bis trimmed at angles 212, 214 substantially as illustrated in FIG. 8J toform a narrow portion at each end of envelope 20. Thus, a distal topsection 164A and a distal bottom section 164B (not shown) are formed.Because the distal top section 164A and the distal bottom section 164Bare separated, pulling the top section 160A coupled to tab 198 throughthe inner 30 surface of sleeve 20B through the second lumen of sleeve20B toward the distal end 164 is simplified. In one embodiment, a tab218 is employed to couple the distal top section 164A and the distalbottom section 164B to one another. As described above with reference tosleeve 20A, the tab 218 may be placed at the end 164 of sleeve 20B toleave an opening between the distal top and bottom sections, 154A and164B, where tab 198 may be accessed and pulled.

[0201] As shown in FIGS. 8F and 8G, sleeves 20A and 20B are joined toform envelope 20. The first lumen 185A and the second lumen 185B formthe single lumen 185 of the envelope 20. Referring now to FIG. 8H, thejoined bottom sections 150B and 160B of sleeves 20A and 20B form hinge200 of envelope 20. Various methods may be employed to join bottomsections 150B and 160B, for example, heat bonding, adhesives, orstaples. Alternative medical grade materials capable of coupling thesections together such as, for example, TYVEK® may be employed. Thelength of hinge 200 may range between about 2.0 inches to about 14.0inches in length. The hinge 200 may be trimmed to a shorter length thatmay be grasped by the operator during the method of implanting theimplant, described below in accordance with FIGS. 9B-9D.

[0202]FIG. 9A illustrates one embodiment of the implant 10 positionedwithin the lumen 185 of the envelope 20. In this embodiment, the overlapregions 150C and 160C, cover the implant 10 enclosed within envelope 20.

[0203] In another embodiment according to the invention, referring toFIGS. 8F, 8G and 8H, the implant 10 is placed within the envelope 20after sleeves 20A and 20B are joined at hinge 200, but prior to tabs 208and 218 being joined to the envelope 20. The implant, for example asling 10, may be manually inserted into lumen 185 of envelope 20. Inanother embodiment, the sling 10 is placed within the first lumen 185Aof the first sleeve 20A manually and/or with the aid of a graspingdevice. Thereafter, sleeve 20B is joined with sleeve 20A to formenvelope 20, with the hinge 200. The remaining portion of sling 10 maybe placed within the second lumen 185B of sleeve 20B prior to or afterforming hinge 200.

[0204] With reference to FIGS. 8A and 9A-9D, in another aspect theinvention includes a method for positioning the implant at an anatomicalsite in the body of a patient. According to one embodiment of thismethod of the invention, the operator positions the envelope 20enclosing sling 10, illustrated for example in FIG. 9A, at theanatomical site, for example, the urethra 999 or bladderneck. Referringto FIGS. 9A and 9B, the operator accesses the tab 208 coupled toproximal top section 154A of envelope 20. Referring to FIG. 9C, tab 208coupled to the proximal end 154 is removed by the operator therebyuncoupling proximal top section 154A from the proximal bottom section154B.

[0205] Referring now to FIG. 9D, the operator grasps hinge 200 andsimultaneously pulls the tab 188 in the direction indicated by arrow189. The force on tab 188 coupled to the top section 150A tears theenvelope 20 along the top portion of the first sleeve 20A. Thereafter,the top section 150A of sleeve 20A is torn away from the envelope 20 ina single piece to expose the implant sling 10. Tab 188, the top section150A, the top of sleeve 20A, and the proximal top section 154A are tornaway from the envelope 20 and the implant sling 10 is exposed. Theexposed portion of the sling 10 is adjacent the urethra 999.

[0206] Still Referring to FIG. 9D, the distal end 164 coupled to tab 218is similarly removed (not shown) and the distal top section 164A and thedistal bottom section 164B are uncoupled. The operator grasps hinge 200and simultaneously pulls tab 198. The force exerted on tab 198 coupledto the top section 160A tears these portions of sleeve 20B away from theenvelope 20. Thus, tab 198, the top section 160A, the top of sleeve 20B,and the distal top section 164A are removed from envelope 20. Theportion of the sling 10 previously enclosed is thereby exposed. Finally,the hinge 200 is removed along with the remainder of envelope 20, andthe sling 10 remains inside the body of the patient at the anatomicalsite where the sling 10 was positioned by the operator, for example, atthe anatomical site of the urethra 999.

[0207] In other embodiment, illustrated in FIG. 9E, the sleeves 20A and20B described in accordance with FIGS. 8D and 8E, further include a cut220A and a cut 220B disposed along the perpendicular axis of, the firstsleeve 20A and the second sleeve 20B respectively. The cuts 220A and220B may be disposed upon the top surface of sleeve 20A, 20B. The cut220A may be sized so that it is equal to or longer then theperpendicular axis of the tab 188 and equal to or longer then theperpendicular axis of the top section 150A, enabling the tab 188 and topsection 150A to be easily pulled through cut 220A. The tab 188 coupledto the top section 150A may be pulled through the cut 220A so that thetab 188 or the tab 188 and at least a portion of top section 150A isadjacent the outer surface 40 of envelope 20. The cut 220B may similarlybe sized with respect to the perpendicular axis of the tab 198 and thetop section 160A. Similarly, the tab 198 coupled to the top section 160Amay be pulled though the cut 220B so that the tab 198 or the tab 198 andat least a portion of top section 160A is adjacent the outer surface 40of envelope 20. Thus, because the tabs 188 and 198 are readilyaccessible from the proximal end 154 and the distal end 164 of envelope20, the tabs 188 and 198 may be pulled to expose the implant 10 housedinside envelope 20 as described above with reference to FIG. 9D. In thisembodiment of the invention, the ends 154 and 164 do not need to beremoved from envelope 20 prior to pulling the tabs 188 and 198.

[0208] In yet another aspect, the invention provides an envelope 20illustrated in FIG. 10A. The envelope 20 includes a sleeve 20C, and tabs188 and 198, that are adjacent the outer surface 40 of the envelope 20.Referring now to FIG. 10B, the sleeve 20C is provided, the longitudinalaxis 22C of sleeve 20C, from the first end 201 to the second end 202,measures from about 12.0 inches to about 84.0 inches in length, and ispreferably about 50.0 inches in length. The sleeve 20C width 24C, asmeasured between the side 203 and the side 204, may have a range fromabout 0.2 inches to about 2.0 inches, preferably between about 0.5inches and about 0.8 inches in length, and most preferably 0.6 inches.Sleeve 20C includes a lumen 185. Also, sleeve 20C includes a top side234 and a bottom side 236.

[0209] As illustrated in FIG. 10C, at about the mid point of the topside 234 of sleeve 20C, a cut 220C is made about perpendicular to thelongitudinal axis 22C of sleeve 20C. Cut 220C has a first side 221C anda second side 222C. The length of cut 220C, measured from the first side221C to the second side 222C, is preferably equal to or less then thewidth of sleeve 20C. In some embodiments, cut 220C ranges fromapproximately 0.2 inches to about 2.0 inches in length. A diagonal cut224 may be made through the bottom side 236 of sleeve 20C. Cut 224 has atop side 225 and a bottom side 226. The diagonal cut 224 is made at anangle of between about 85° and about 5°, preferably about 45° relativeto cut 220C. The length between the diagonal cut 224 top side 225 andthe first side 221C of cut 220C will vary according to the width 24C ofsleeve 20C and the angle of diagonal line 224, in one embodiment thislength ranges from about 0.1 inches to about 1.5 inches, and ispreferably 0.3 inches. The distance between the diagonal cut 224 bottomside 226 and the second side 222C of cut 220C will similarly vary, andin one embodiment this length ranges from about 0.1 inches to about 1.5inches, and is preferably 0.3 inches. In one embodiment, diagonal cut224 is perforated along its length.

[0210] Referring still to FIG. 10C, the first end 201 of sleeve 20C istrimmed to form a first top 201A and a first bottom 201B of sleeve 20C,such that where trimmed the lumen 185 has two separate pieces, 201A and201B. Similarly, the second end 202 of sleeve 20C is trimmed to form twoseparate pieces, namely, the second top 202A and second bottom 202B. Thefirst top 201A is trimmed such that its width is equal to or less thenthe inner diameter of sleeve 20C, i.e. the lumen 185. Similarly, thesecond top 202A is trimmed to a width that is equal to or less then thediameter of lumen 185.

[0211] In some embodiments, the free end of the first top 201A includesa tab 188. Similarly the free end of the second top 202A includes a tab198. Tabs 188 and 198, that are connected to the first top 201A and thesecond top 202A respectively, may be constructed as described above withreference to tab 188 and FIG. 8C.

[0212] Referring now to FIG. 10D, the tab 188 joined to the end of thefirst top 201A is folded into the lumen 185 and laced through lumen 185.The tab 188 joined to the first top 201A are pulled through cut 220C, sothat the tab 188 and/or a portion of the first top 201A is exposed onthe outer surface 40 of sleeve 20C.

[0213] As shown in FIG. 10D, the tab 198 joined to the end of the secondtop 202A is folded into the lumen 185 and laced through lumen 185.Thereafter, the tab 198 joined to the second top 202A is folded intolumen 185 and laced through lumen 185, where finally it is pulledthrough cut 220C, such that tab 198 and/or a portion of the second top202A is also exposed on the outer surface 40 of sleeve 20C. After bothtabs adjacent to top sections are laced through lumen 185 and pulled outcut 220C, the first top 201A is adjacent the second top 202A and bothare enclosed within cut 220C. In one embodiment, as illustrated in FIGS.10B-10E, a diagonal cut 224 is placed on the sleeve 20C. The diagonalcut 224 may simplify lacing the tab 188 and first top 201A and the tab198 and second top 202A through lumen 185 and into cut 220C. In anotherembodiment, a single cut, for example a diagonal cut 224 or a cut 220C,is disposed through only one side, i.e., either the top side 234 or thebottom side 236 of the sleeve 20C. In one embodiment according to theinvention, as shown in FIG. 10E, a tab 208 is placed at the free end ofthe first bottom 201B, similarly, a tab 218 is placed at the free end ofthe second bottom 202B. The tabs 208 and 218 may be made of adhesivetape, glued paperboard, or other materials as described above withreference to tab 188 and FIG. 8C. The tabs 208 and 218 may be employedin positioning the envelope inside the body of a patient.

[0214]FIG. 10F illustrates one embodiment of the implant 10 positionedwithin lumen 185 of the envelope 20, described above with reference toFIGS. 10A-10E. In one embodiment, the envelope includes a material thatis easily torn includes a material that is easily torn. Such easily tornmaterials are described above with reference to FIGS. 1A, 1B, 2A, 2B,3A, and 3B and may include, for example, a material with a molecularorientation, such as a linear low density polyethylene. The implant 10may be placed within lumen 185 of envelope 20 manually or with the aidof a grasping device. In one embodiment, the implant 10 is placed intothe lumen 185 after both tabs 188 and 198 and/or both the first top 201Aand the second top 202A are laced through cut 220C of sleeve 20C.

[0215] As illustrated in FIG. 10F the envelope 20 encloses the implant10, for example, a mid-urethral sling. In another aspect, the inventionincludes a method for positioning the implant at an anatomical site inthe body of a patient. In one embodiment (not shown), the length of thefirst top 201A and the length of the first bottom 201B align to enabletabs 188 and 208 to lie about adjacent when envelope 20 lays flat.Eyelets or holes positioned through the first top 201A and the firstbotton 201B of envelope 20 align to form a coupling ring 355, describedbelow with reference to FIGS. 23D and 23F, which may be attached to thedelivery assembly 650 cannula 600 for implantation in the patient'sbody. Similarly, eyelets positioned through the second top 202A andsecond bottom 202B align to form a coupling ring 355 that may beemployed to implant the envelope 20 in the patient's body.

[0216] According to one embodiment of the method of the invention, theoperator positions the envelope 20 enclosing sling 10 at the anatomicalsite, for example as illustrated in FIGS. 10A and 10F, the urethra 999.In one embodiment, when the envelope 20 enclosing sling 10 is positionedadjacent the urethra 999, the bottom side 236 of the envelope 20 isadjacent the urethra. Thus, the tabs 188 and 198 and the associatedportions of the first top 201A and the second top 202A, respectively,are visible from the patients vagina. In one embodiment, during theplacement procedure, the operator positions the tabs 208 and 218 so thatthey are on the external part of the patient's body, for example, thetabs 208 and 218 are external to the patient's pelvis or abdomen.

[0217] Once positioned, the operator accesses the tab 188 joined to thefirst top 201A and tab 198 joined to the second top 202B, which arelocated in the area of the patients vagina. The operator grasps tab 188coupled to the first top 201A and pulls the tab 188 in the direction of190. The force on tab 188 coupled to the first top 201A tears a portionof the top side 234 of envelope 20. Thereafter the operator grasps tab198 coupled to the second top 202A and pulls the tab 198 in thedirection of 190. Similarly the force on tab 198 coupled to the secondtop 202A tears the remaining portion of the top side 234 of envelope 20.Finally the operator pulls the tab 208 to remove the bottom side 236 ofenvelope 20 from the body of the patient. In some embodiments, thebottom side 236 may be split into two pieces, for example, in the areaof diagonal cut 224, accordingly, in such cases both the tab 208 coupledto the first bottom 201B and the tab 198 coupled to the second bottom202B will be pulled away from the direction of the patients body.

[0218] In another embodiment, the implant 10 longitudinal axis is atleast equal to the length of the envelope 20. In this embodiment, theimplant 10 may be held within the envelope 20 by the tabs 208 and 218,for example, where the tabs are adhesive, the implant may be held withinthe envelope 20 by the tabs 208 and 218 disposed at each end of theenvelope 20. In such embodiments, during the placement procedure, afterthe tabs 208 and 218 are external to the patient's body, the operatormay uncouple the tabs 208 and 218, freeing implant 10. According to thismethod of the invention, the tabs 208 and 218 are uncoupled prior toremoving the envelope 20 from the body of the patient.

[0219] In another aspect, the invention relates to an attachment piece350 for attaching the sling 10 or the envelope 20 enclosing the sling10, to a delivery assembly 650. In one embodiment of the inventionillustrated in FIG. 11A, the attachment piece 350 includes a firstmember 400, such as a cylinder member 400. The cylinder member 400 ofattachment piece 350 is engageable with a dilator tube member 500 of adelivery assembly 650, as described below.

[0220] Referring still to FIG. 11A, the cylinder member 400 is hollowhaving a least one lumen 418 and is substantially cylindrical surroundedby a wall 414. The cylinder member 400 further includes a first portion410 at one end of the cylinder, and a second portion 420 at the oppositeend of the cylinder. The height of cylinder member 400 is in the rangeof 0.1 to 1.0 inches, preferably 0.3 inches, and has an outer diameterin the range of 0.1 inches to 0.6 inches, preferably 0.19 inches.Cylinder member 400 is manufactured from materials such as, for example,polyethylene/ethylene vinyl acetate (EVA) blend, polyethylene, nylon,polypropylene, and thermoplastic FEP.

[0221] The cylinder member 400 is divided into a first portion 410 atone end of the cylinder and a second portion 420 at the end opposite tothe first portion 410. The length of the first portion 410 is 20-40% andthe length of the second portion 420 at the opposite end of the cylinderis 60-80% of the total length of the cylinder member 400. In oneembodiment of the invention, an appendage 430 extends laterally outwardfrom the wall 414 of the cylinder member 400 at the interface 412 of thefirst portion 410 of the cylinder member 400 and the second portion 420of the cylinder member 400 as shown in FIG. 11A.

[0222] Referring still to FIG. 11A, in one embodiment according to theinvention, cylinder member 400 further includes an appendage 430 whichextends from the side of the cylinder member 400 at about one-third ofthe distance along the long axis of the cylinder member 400 from a firstend 415 to a second end 417. Appendage 430 is substantially flat. Theshape of appendage 430 permits appendage 430 to flex up or down,depending on which direction it is moved through the body of thepatient. Appendage 430 conforms to the shape of the delivery assemblydilator tube when the cylinder member 400 is moved through the patient'stissue, described below. Appendage 430 is bonded, such as molded orotherwise securely attached, to the cylinder member 400. Appendage 430measures in the range of about 0.2 to 1.0 inches in width and 0.5 to 2.0inches in length, preferably, 0.6 inches by 1.0 inches. Materials usedin the manufacture of appendage 430 include, but are not limited to,polyethylene/ethylene vinyl acetate blend, polyethylene, nylon,polypropylene, and thermoplastic FEP. The appendage 430 is manufacturedfrom materials that are sufficiently flexible to pass through thepatient's tissue without tearing, or otherwise traumatizing the tissue.The appendage 430 is bonded to the cylinder member 400 by an adhesive,heat sealing, or other means known to the skilled person. In oneembodiment, the cylinder member 400 is heat bonded to the envelope 20material. Alternatively, appendage 430 and cylinder member 400 aremanufactured as a single piece, for example, by injection molding.

[0223] Referring now to FIG. 11B, a free end 435 of appendage 430 isattachable to the free end 436 of an envelope or sleeve 20 enclosing theimplant 10, for example, an implantable sling 10 used for treatment offemale urinary incontinence. Alternatively, the free end 435 ofappendage 430 is attachable to, for example, a free end 434 of theimplantable device 10. In yet another embodiment, according to theinvention, the free end 434 is bonded, or otherwise securely attached,to the cylinder member 400.

[0224] Thus, accordingly to the invention, the implantable device 10 isbonded, or otherwise securely attached, to the cylinder member 400. Theimplantable device 10 is not clamped, clipped, or pierced. Accordingly,the implantable device 10 other than being bonded to a member 400, isfree to be manipulated in a plurality of planes when it is introducedinto the patient's body.

[0225] The free end 435 of the appendage 430 and the free end 436 of theenvelope 20, are attached by, for example, heat bonding, suturing oradhesive bonding. If heat is used to bond the appendage 430 to theenvelope 20, the glass transition range of the materials used tomanufacture the appendage 430 and the envelope 20 must be similar topermit a satisfactory bond joint. In a particular embodiment of theinvention, the appendage 430 and the envelope 20 are manufactured fromthe same materials, for example, the material used to manufactureappendage 430 and envelope 20 may be polyethylene.

[0226] Referring now to FIG. 12A, a dilator tube 500 includes anelongated hollow member 510 and a tip 520, for example, a conical tip.The elongated hollow member 510 is 4.0 to 14.0 inches, preferably 8.0inches in length, and 0.2 to 0.4 inches, preferably 0.25 inches, inouter diameter. The lumen of the elongated hollow member 510 is 0.1 to0.7 inches in diameter, preferably 0.19 inches in diameter and isenclosed by tube wall 516. Tube wall 516 is 0.01 to 0.08 inches thick,preferably 0.03 inches. The hollow elongated member 510 terminates atend 560 where it abuts the conical tip 520. Materials used tomanufacture dilator tube 500 include, but are not limited to,polyethylene, polypropylene, and nylon.

[0227] Referring to FIG. 12B, the conical tip 520 is hollow andcone-shaped. The base 514 of the conical tip 520 is configured to abutthe end 560 of the elongated hollow member 510. In one embodiment,referring again to FIG. 12A, the conical tip 520 includes an aperture402.

[0228] Illustrated in FIG. 12A, in one embodiment, according to theinvention, the wall 516 of dilator tube 500 includes a cut 512 which issubstantially perpendicular to the long axis of elongated hollow member510 and is positioned near or substantially adjacent to the base 514 ofthe conical tip 520. The cut 512 forms the distal end 560 of theelongated member 510 and extends through nearly the entire circumferenceof the wall of dilator tube 500 but stops short of severing the conicaltip 520 from the elongated hollow member 510 of the dilator tube 500.Accordingly, a flap 518 of wall 516 remains joining the conical tip 520to the elongated member 510. The flap 518 thus acts as a hinge, asillustrated in FIG. 13, permitting at least 90°, preferably 180° ofarticulation of the conical tip 520 relative to the long axis of theelongated member 510. Other means of attaching the conical tip 520 tothe wall 516 other than those illustrated are also contemplated by theinvention and are not limited to those illustrated.

[0229] Referring to FIG. 13, in one embodiment of the invention, acannula 600, described in greater detail below, is inserted into thelumen 540 of the elongated hollow member 510 of the dilator tube 500.The cannula 600 may be advanced in the lumen 540 of the hollow member510 until the end 602 of the cannula 600 emerges from an opening 542formed at the end of the elongated hollow member 510 substantiallyadjacent the hinge 518.

[0230] Referring now to FIGS. 11A-11N, in one embodiment of theinvention, the top 415 of the cylinder member 400 includes one or moreslits 416 which extend through the top 415 into the lumen 418 of thecylinder member 400. As illustrated in FIG. 11A, in one embodiment ofthe invention, the slits 416 through the top 415 of cylinder member 400may be in the shape of an “X.” Embodiments of the slits 416 are notlimited to those illustrated and may include, for example, Y-shape,V-shape, O-shape, or curvilinear. In one embodiment, the top 415 of thecylinder has a conical shape, which is slit by the one or more slits416. The shape of the top 415 and/or the slits 416 provide the cylindermember 400 with a shape that assures that there is one way to place thecylinder member 400 into the lumen 540 of dilator tube 500. Additionalmeans or shapes that ensure one way placement of member 400 may beemployed. In the illustrated embodiment, the member 400 is shaped as acylinder so that it mates with the lumen 540 of the hollow member 510 ofdilator tube 500. Accordingly, other suitable mating dilator tube 500lumen 540 and cylinder member 400 shapes may be selected, such as, forexample, square, triangle, rectangle, or star. In one embodiment, theslits 416 permit one-way assembly of cylinder member 400 over thecannula 600, described below.

[0231] The second portion 420 of the cylinder member 400 is cylindricalin shape and hollow. The height of the second portion 420 is 0.07 to 0.7inches, preferably 0.2 inches, or 2-3 times the height of the firstportion 410 of the cylinder member 400. The dimensions of the secondportion 420 are configured to enable the second portion 420 to be seatedwithin the lumen 540 of the dilator tube 500, described below. Thedimensions of the first portion 410 and the second portion 420 ofcylinder member 400 may be configured to permit the cylinder member 400to enter the lumen 540 of dilator tube 500 one way, i.e., so that thesecond portion 420 is inserted into the dilator tube 500 lumen 540.These dimensions are selected to prevent inadvertent introduction of thefirst portion 410 of cylinder member 400 into the lumen 540 of thedilator tube 500. This one way configuration of the cylinder member 400with the lumen 540 of dilator tube 500 assures proper positioning of theimplant 10 inside the patient's body. In one embodiment of theinvention, the free end 417 of the second portion 420 of cylinder member400 has a chamfered edge to permit its ease of location in the lumen 540of dilator tube 500.

[0232] Referring now to FIG. 14, the cylinder member 400 attached byappendage 430 to an implant device such as the envelope 20 enclosing thesling 10, is introduced into the lumen 540 of the elongated member 510of the dilator tube 500. The cylinder member 400 is seated into thelumen 540 of the elongated member 510 of dilator tube 500 therebyanchoring the cylinder 400 to the dilator tube 500. The cannula 600 isintroduced from the lumen 540 of the dilator tube 500 into the lumen 418of the hollow cylinder member 400 until the end 602 of the cannula 600emerges from the top 415 of the cylinder member 400 through the slit 416as illustrated in FIG. 15.

[0233] Referring now to FIG. 16, with the end 602 of the cannula 600extended beyond the end 415 of the cylinder member 400, the conical tip520 of the dilator tube 500 is rotated over the top of the first portion410 of the cylinder member 400. Thus, as illustrated in FIG. 17, theappendage 430 of the cylinder member 400 is trapped between the distalend 542 of the elongated member 510 of dilator tube 500 and the bottom514 of the conical tip 520 of dilator tube 500. In this position, theconical tip 520 encloses the first portion 410 of the cylinder member400 thereby joining the sling 10, or the envelope 20 and the sling 10,by the appendage 430 to the dilator tube 500 of the delivery assembly650.

[0234] Referring still to FIG. 17, the cannula 600 can be furtherextended through the slits 416 in the top 415 of the cylinder member400, and through the aperture 402 at the end of conical tip 520. Whenthe end 602 of cannula 600 emerges through the aperture 402 at the endof the conical tip 520, the conical tip 520 is fixed in position and cannot move laterally thereby locking the sling 10 to the dilator tube 500of the delivery assembly 650.

[0235] Referring now to FIG. 18A, in another embodiment according to theinvention, the attachment piece 350, includes a cone 460 and a collet580. The cone 460 is bonded to the implant 10 or envelope 20 by adhesivebonding, heat bonding, suturing, or any other bonding means known to theskilled person. In one embodiment, referring now to FIGS. 1A and 18A,the width 24 of the first end 201 of envelope 20 is heat bonded about aportion of the outer diameter of cone 460 at attachment site 466. In oneparticular embodiment, width 24 of the first end 201 of envelope 20covers about one half of the outer circumference of cone 460 atattachment site 466. The cone 460 and collet 580 are manufactured frommaterials such as polypropylene, nylon, acrylonitrile butadiene styrene(ABS), polycarbonate, preferably polyethylene or polyethylene/ethylenevinyl acetate blend to permit heat bonding to the sleeve. The cone 460and collet 580 may be manufactured by injection molding.

[0236] With continued reference to FIG. 18A, the collet 580 is generallycylindrical, includes a lumen 590 and measures about 0.3 inches to 0.9inches, preferably about 0.6 inches in length and 0.1 inches to 0.7inches, preferably 0.3 inches in diameter at the widest point. A firstend portion 582 of the collet 580, illustrated in FIG. 18A, is a hollowcylinder and occupies about 25-50% of the length of the collet 580. Thesecond end portion 584 of the collet 580, illustrated in FIG. 18A, istapered from the first end portion 582 to the second end 585 of thecollet 580. In one embodiment, the first end portion 582 of the collet580 is inserted into the lumen 540 of the elongated hollow member 510 ofthe dilator tube 500 and bonded into the dilator tube. In embodimentswhere the collet 580 is bonded into the distal end 560 of the elongatedhollow member 510 of the dilator tube 500, the cone 520 may be removedfrom the dilator tube 500. An aperture 592 is positioned at end 585 ofthe collet 580. The tapering of the collet 580 enables ease of passagethrough tissues in the patient's body when the attachment piece 350 isadvanced without the cone 460 in place.

[0237] Referring still to FIG. 18A, a pair of cantilever locking tabs586 are positioned on the outside surface of the tapered second portion584 of the collet 580. The cantilever locking tabs 586 deflect inwardwhen an exterior force is applied and the tabs 586 return to theiroriginal position to provide a snap engagement with a correspondinglocking receptacle 462 on the cone 460, described below.

[0238] Referring still to FIG. 18A, a stabilizing bump 588 is providedon the cantilever locking tab 586 to stabilize the cantilever lockingtabs 586 when the tabs 586 are engaged with the cone 460. Thestabilizing bump 588 locks the collet 580 onto the cone 460.

[0239] With continued reference to FIG. 18A, in one embodiment, the cone460 of the attachment piece 350 includes a substantially rectangularlocking receptacle 462 positioned in the wall 463 in the lumen 465 sidenear the first end 461 of the cone 460. The cantilever locking tabs 586in the collet 580 engage the locking receptacle 462 to secure the collet580 to the cone 460. The number of locking receptacles 462 on the collet580 are at least as many as the number of cantilever locking tabs 586positioned on the cone 460. In another embodiment of the invention, thelocking receptacle 462 is a continuous receptacle (not shown) thatencircles the wall 463 on the lumen 465 side of the cone 460.

[0240] The cone 460 tapers from the cone first end 461 to a cone secondend 464. In one embodiment, an aperture 470 is positioned at the secondend 464. The taper of the cone 460 parallels the taper of the secondportion 584 of the collet 580. The similar tapers of the cone 460 andthe second portion 584 of the collet 580 enable the second end 584 ofthe collet 580 to fit snugly within the lumen 465 of the cone 460. Thecone 460 includes a surface 468 on the outside surface of the cone 460for attachment of the implant 10 or sleeve 20.

[0241] Referring to FIG. 18B, to lock the cone 460 with the implantattached at surface 468 to the collet 580, the second end portion 584 ofcollet 580 is introduced into the lumen 465 of the cone 460. Thecantilever locking tabs 586 and stabilizing bump 588 fit into thecorresponding locking receptacles 462 on the cone 460 to secure thecollet 580 to the cone 460. The interface between the cone 460 andcollet 580 must be sufficiently secure to withstand between about a 0.5pound to about a 10 pound, preferably a four pound separation force. Acannula 600 may be introduced through the lumen 590 of the collet 580,the lumen 465 of the cone 460, the aperture 592 of the collet 580, andthe aperture 470 of the cone 460. In one embodiment, cannula 600 issized to fit snugly inside lumen 590 of the collet 580. The presence ofcannula 600 in lumen 590 of the collet 580 prevents locking tabs 586from deflecting inward. The cannula 600 and the attachment piece 350including the cone 460 and the collet 580 may be used to introduce theimplant 10 or envelope 20 joined to the cone 460 into the body of thepatient. With the collet 580 locked to the cone 460, the collet 580 cannot be removed from the cone 460 without deflecting the locking tabs586. The cone 460 provides a smooth transition from the leading cannula600 to the dilatation feature of the collet 580. With the cannula 600inserted in the attachment piece 350, the cantilever tabs 586 are fullyengaged in the receptacle 462 of the cone 460 locking the cone andcollet of the attachment piece 350 together preventing the cantilevertabs 586 from deflecting until the attachment piece 350 is removed fromthe cannula 600.

[0242] In another embodiment of the invention, the cone 460 includes anorientation key to permit assembly of the cone 460 to a predeterminedorientation on the collet 580 during assembly of the attachment piece350.

[0243] In another aspect, referring again to FIG. 11A, the invention isa method for attaching a medical device 10, such as a sling implant 10for the treatment of female urinary incontinence, to a delivery assembly650. According to one embodiment of the method of the invention, thecylinder member 400 is pre-attached via appendage 430 to the implant 10or to the envelope 20 enclosing the implant 10. An operator, such as aphysician, seats the second portion 420 of the cylinder member 400 intothe lumen 540 of the elongated hollow member 510 of the dilator tube 500to anchor the cylinder member 400 in the dilator tube 500. Conical tip520 is rotated about hinge 518 until the conical tip 520 is seated overthe first portion 410 of the cylinder member 400. The cannula 600 isadvanced towards the top 415 of the cylinder member 400 until the end602 of the cannula 600 emerges through slits 416 in the top 415 of thecylinder member 400. The cannula 600 is further advanced until the end602 of the cannula 600 emerges through the aperture 402 in the conicaltip 520.

[0244] In another embodiment of the invention, the delivery system 2 ofthe invention includes a delivery assembly 650. Referring now to FIG.19A, in one embodiment, the delivery assembly 650 includes the dilatortube 500, the cannula 600, a retractable point 740, and a deliveryhandle 700. The retractable point 740 is operatively joined through thedistal end 714 of the handle 700 to button 713 and button 715, describedbelow, on the handle 700. The dilator tube 500 is operatively joined toan extender button 717 positioned on an elongated member 710 of thehandle 700.

[0245] Referring now to FIGS. 19A-19H, in one embodiment according tothe invention, handle 700 includes the elongated member 710 having aproximal end 712 that is furthest from the conical tip 520 of thedilator tube 500, and a distal end 714 that is closest to the conicaltip 520 of the dilator tube 500. Elongated member 710 of the handle 700has at least one lumen 709, illustrated in FIG. 20D, which parallels thelong axis of the handle 700. Elongated member 710 is about 4.0 inches to14.0 inches, preferably 8.0 inches in length and about 0.5 inches to 5.0inches, preferably 1.5 inches in diameter. Handle 700 has a proximalbutton 713, a distal button 715, and an extender button 717.

[0246] In one embodiment of the invention, the proximal button 713 ispositioned on the surface of the elongated member 710 at the proximalend 712 on one side of the handle 700. In a particular embodimentaccording to the invention, the distal button 715 is positioned on theelongated member 710 at the distal end 714 of the elongated member 710on the same side of the handle 700 as the proximal button 713. In oneembodiment according to the invention, the extender button 717 ispositioned on a side other than the side of the handle 700 on which theproximal button 713 and distal button 715 are positioned. For example,referring to FIG. 19A, the extender button 717 is positioned on the sideof the elongated member 710 of the handle 700 opposite to the side ofthe elongated member 710 on which the proximal button 713 and the distalbutton 715 are positioned. In another embodiment, the extender button717, proximal button 713, and the distal button 715 are positioned onthe same side of the handle 700.

[0247] Referring again to FIG. 19A, the dilator tube 500, describedabove, slides in and out of and extends outwardly from the distal end714 of the elongated member 710 of the handle 700. The conical tip 520of the dilator tube 500 is positioned at the distal end of the dilatortube 500. Referring now to FIGS. 20A and 20B, a bushing 724 is insertedinto the proximal end 726 of the dilator tube 500. A cuff 718 isattached to the extender button 717 and rings the exterior of theproximal end 726 of dilator tube 500. In one embodiment, extender button717 and cuff 718 are manufactured as a single unit by, for example,injection molding. In one embodiment, the bushing 724 is sized so thatthe dilator tube 500 fits snugly inside cuff 718. The bushing 724maintains dilator tube 500 inside cuff 718 and retains dilator tube 500inside the handle 700.

[0248] Referring now to FIGS. 20C and 20D, the dilator tube 500 ismanually slideably moveable by the extender button 717 from a firstposition, illustrated in FIG. 20C, in which the dilator tube 500 is in afirst or extended position from the distal end 714 of the elongatedmember 710 of the handle 700, to a second or retracted position,illustrated in FIG. 20D, in which the proximal end 726 of the dilator500 is withdrawn into the lumen 709 of the elongated member 710 of thehandle 700 to a position substantially adjacent the proximal end 712 ofthe elongated member 710 of the handle 700.

[0249] In another embodiment of the dilator tube 500, illustrated inFIG. 20E, a rigid ring 523 is attached to the inside wall in the lumen540 of the dilator tube 500 approximately 0.5 to 3.0 inches, preferably1.3 inches from the end 542 of the elongated hollow member 510. Therigid ring 523 serves as a guide for passage of the cannula 600 in thelumen 540 of the dilator tube 500. In another embodiment, more than onerigid ring 523 is present in the elongated member 510 of dilator tube500 and/or within conical tip 520 of dilator tube 500. The rigid rings523 guide and stabilize cannula 600 placement within the lumen ofdilator tube 500 and the rigid ring 523 may be placed to direct cannula600 into the center of dilator tube 500. In one embodiment, the rigidrings 523 are tapered to an angle and become gradually flush with theinner diameter of the dilator tube 500 lumen, to assist in positioningcannula 600 within dilator tube 500. In yet another embodiment, therigid ring 523 is an insert such as a tubular insert that may beinserted into, for example, the elongated member 510 and/or the conicaltip 520 of dilator tube 500. The outer diameter of such an insert mayclosely correspond to the inner diameter of the elongated member 510 inone embodiment, the outer diameter of the insert is about 0.2 inches andthe inner diameter is about 0.14 inches. In one embodiment, the insertis joined to the elongated member 510 by, for example, heat bonding.Referring now to FIGS. 21A, 21B, and 21C, the cannula 600 is a secondhollow elongated tube 604. The cannula 600 is inserted within the lumen540 of the dilator tube 500, illustrated in FIG. 21B. In a particularembodiment, according to the invention, the tube 604 of cannula 600forms an arc from the cannula tip 602 at the distal end of the cannula600, to about 10-75% of the length of tube 604. For example, referringto FIG. 19A, cannula 600 forms an arc with the concave surface of thearc on the same side of the cannula 600 as buttons 713 and 715 of thehandle 700. The arc of the cannula 600 is selected to optimize the easeof insertion of the delivery system through the patient's tissues toposition the implant 10 at the appropriate anatomical site. Cannula 600is about 4.0 inches to about 14.0 inches, preferably 8.0 inches inlength, and about 0.05 inches to about 0.3 inches, preferably 0.13inches in diameter. Cannula 600 is approximately the same length as thedilator tube 500. In the most extended first position of dilator tube500, substantially the entire length of the cannula 600 is surrounded bythe dilator tube 500 as illustrated in FIG. 20C. When the dilator tube500 is in its most retracted second position, approximately 20-50% ofthe cannula 600 is surrounded by the dilator tube 500 as illustrated inFIG. 21C. Cannula 600 is rigid and is manufactured from materials, suchas stainless steel, plated carbon steel, or coated carbon steel.

[0250] Referring now to FIGS. 22A, 22B and 22C, the retractable point740 according to the invention includes an elongated member 742 with atapered end 744 at the distal end 741 of the elongated member 742. Theelongated member 742 of the retractable point 740 is about 4.0 inches toabout 14.0 inches, preferably 8.0 inches in length and 0.03 inches toabout 0.1 inches, preferably 0.06 inches in diameter. The elongatedmember 742 of the retractable point 740 traces an arc corresponding tothe arc of the cannula 600. The retractable point 740 is positioned inthe lumen 610 of the cannula 600 as illustrated in FIG. 22B. Theretractable point 740 is moveable from an extended first positionillustrated in FIG. 22C to a retracted second position illustrated inFIG. 20C.

[0251] Referring now to FIG. 23A, the proximal button 713 and the distalbutton 715 on the handle 700 are each operatively joined to theretractable point 740 and are moveable through two positions, a firstposition A and second position B. Referring now to FIGS. 22A and 22C, inthe first position A, the tapered end 744 of the retractable point 740is retracted into the cannula 600. In the second position B, the taperedend 744 of the retractable point 740 is extended from the distal end 602of the cannula 600, for example, as illustrated in FIG. 22C. The buttons713 and 715 are spring biased to the first position from the secondposition requiring the operator to manually hold the button 713 or 715to maintain the button in the second position to extend the tapered end744 from the distal end 602 of the cannula 600. Referring again to FIGS.20D, 22A and 22C, when the proximal button 713 is held down a projection707, located under button 713, is pushed toward the distal end 714 ofdelivery handle 700, which moves bar 705 forward toward distal end 714.Retractable point 740 is housed inside bar 705 and is secured inside bar705 by bolt 743. When proximal button 713 is held down pushingprojection 707 toward the distal end 714 of handle 700, the bar movestoward the distal end 714 of handle 700. Accordingly, point 744 extendsin the distal direction and outside cannula 600. Similarly, becauseprojection 708, seated under distal button 715, is inclined in the samedirection as projection 707, when button 715 is held down, point 744extends in the distal direction and outside cannula 600.

[0252] In another embodiment of the delivery assembly 650, the cannula600, illustrated in FIG. 23B, the portion of the cannula 600 near thedistal end 602 of the cannula 600 includes a locking notch 615 to permitattachment of a coupling ring 355 to the cannula 600. The coupling ring,illustrated in FIGS. 23D and 23F, is a loop attached to an end of theimplant 10, or a hole or an eyelet positioned in the end of the implant10, for coupling to the cannula notch 615. The loop may be formed by,for example, a suture or a wire, and a loop may be anchored to the endof the implant 10 by, for example, adhesive, heat sealing, being boltedto the end of the implant 10, being threaded through the implant 10, orby other available attachment means. In another embodiment (not shown),a coupling ring 355 is positioned through one or more ends of anenvelope 20 to permit joining the envelope 20 to the locking notch 615of cannula 600.

[0253] As illustrated in FIG. 23B, in this embodiment of the invention,button 713 and button 715 have three position buttons, position A,position B and position C. In position A of button 713 and button 715,the notch 615 is in the open, unlocked position ready to receive acoupling ring 355. In position B of button 713 and button 715, the notch615 is in the closed, locked position, as illustrated in FIG. 23C. Inposition B, the coupling ring 355 is locked in the notch. In position Cof button 713 and button 715, the retractable point 740 is extended fromthe distal end 602 of the cannula 600. Position C of the button 713 andbutton 715 is spring-biased to position B such that the operator musthold the button in position C to extend the retractable point 740.

[0254] In another embodiment, the cannula 600 or the distal end portionof the cannula 600 is detachable from the delivery assembly 650.

[0255] Another aspect of the invention includes a method for deliveringan implantable device 10 to an anatomical site in the body using thedelivery assembly 650 according to the invention. An anatomical siteincludes, for example, the mid-urethra, prostate or neck of the urinarybladder. According to one embodiment of the method, a transvaginalapproach is used with the envelope 20 enclosing implant 10, such as, forexample, a PINNACLE Sling manufactured by Boston Scientific Corporation,Natick, Mass. The sling 10 is secured to the delivery assembly 650 byfirst bonding the sling 10 to the cylinder member 400 by heat bonding,adhesive or by other methods known to the skilled person. The dilatortube 500 is placed in the extended position illustrated in FIG. 20C bymoving extender button 717 on the delivery handle 700 from position E toposition D illustrated in FIG. 23A. The conical tip 520 of the dilatortube 500 is manually opened to the position illustrated in FIG. 20C(also see FIG. 11A). The second portion 420 of the cylinder member 400is seated in the lumen 540 of the hollow elongated member 510 of thedilator tube 500, as illustrated in FIGS. 14 and 15. Conical tip 520 ismanually rotated over the first portion 410 of the cylinder member 400,as shown in FIG. 16. Thus, the sling 10 is attached by attachment piece350 to the delivery assembly 650 as shown in FIG. 17. After the sling 10is secured to the dilator tube 500, the dilator tube 500 is moved fromthe extended position illustrated in FIG. 20C to the retracted positionillustrated in FIG. 21C, by moving button 717 from position D toposition E illustrated in FIG. 23A. The operator grasps the handle 700and, in the transvaginal approach, advances the distal end 602 of thecannula 600 transvaginally to emerge through the rectus fascia,abdominal fasica and the abdominal wall in the region of the pubictubercle of the patient. After confirming the correct position forplacement of the sling 10 in the area of the mid-urethra, the dilatortube 500 is advanced over the cannula 600 by moving extender button 717from the first position E to the second position D thereby advancing thedilator tube 500 distally over the cannula 600. The cannula 600 anddilator tube 500 are further advanced in the patient's tissues until thesling 10 extends through the rectus fascia. The sling 10 is disconnectedfrom the attachment piece 350 by, for example, cutting, and the cannula600 and dilator tube 500 are withdrawn from the patient. The procedureis repeated on the opposite side of the patient.

[0256] In another embodiment, the lumen 709 of delivery handle 700 hasone or more locking regions in which dilator tube 500 may be locked inplace as the operator moves dilator tube 500 from the first position Eto the second position D. According to this embodiment, the operator mayuse both cannula 600 and dilator tube 500 to push through the rectusfascia, abdominal fascia and the abdominal wall when traversing from thevagina to the region to the pubic tubercle of the patient during theprocedure. According to this embodiment, the sling 10 may be attached tothe delivery assembly 650 prior to moving the dilator 500 and cannula600 through the patient's tissue. Alternatively, the sling 10 may beattached to the delivery assembly 650 only after the tissue has beeninitially penetrated.

[0257] In an alternative approach to this method, the mid-urethra isapproached percutaneously through the abdominal wall, abdominal fascia,and the rectus fascia rather than transvaginally as described above. Inthis method according to the invention, the dilator tube 500 is advancedover the cannula 600 by moving extender button 717 on the handle 700from first position E to the second position D. In one embodiment, theextender button 717 is reversibly moveable through a plurality ofpositions from the first position E to the second position D. As shownin FIG. 23A, the proximal button 713 is moved from position A toposition B to extend the tapered end 744 of the retractable point 740beyond the distal end 602 of the cannula 600. By firmly grasping thehandle 700, the cannula 600, with retractable point 740 extended anddilator tube 500 extended, is advanced through the rectus fascia in theregion of the pubic tubercle. The cannula 600 and dilator tube 500 areadvanced until they emerge from an incision in the vaginal wall. Thesling 10, attached to the attachment piece 350, is secured to thedelivery assembly 650 as described above. The cannula 600 and dilatortube 500 with the attached sling 10 are pulled back into the incisionuntil the sling 10 is placed in the correct position in the region ofthe mid-urethra. Once positioning of the sling 10 is confirmed, thesling 10 is disconnected from the attachment piece 350 and stabilizedwith forceps. The cannula 600 and the dilator tube 500 are withdrawnfrom the body. The same steps are repeated on the opposite side of thevagina.

[0258] Another embodiment of the method for implanting an implant 10 atan anatomical site in the body of a patient includes the steps ofproviding an implant 10 enclosed in an envelope 20. The method furtherincludes coating the envelope 20 with at least one drug, such as anantibiotic, on the inner surface, the outer surface, or both the innerand outer surface of the envelope. The method according to the inventionmay further include the step of providing a therapeutic drug dispersedon the envelope to the patients tissues.

[0259] In another embodiment, the method of the invention may furtherinclude the steps of positioning the implant 10 enclosed within theenvelope 20 at the anatomical site in the body, and removing theenvelope 20 while the-implant 10 remains positioned at the anatomicalsite in the body of the patient. In yet another embodiment, the methodof the invention may further include tearing the envelope 20 at thetearable region 50 of the envelope 20, and removing the envelope 20 fromthe body.

[0260] In another embodiment, the method of the invention includes thestep of providing a spacer 100 to position the implant 10 at the targetanatomical site in the patient's body. The method may further includethe step of measuring the tension applied to the sling 10 by a pressuresensor 101.

[0261] Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention asclaimed. Accordingly, the invention is to be defined not by thepreceding illustrative description but instead by the spirit and scopeof the following claims.

What is claimed is:
 1. A system for implanting an implant at ananatomical site in the body of a patient, comprising: an envelopecomprising an inner surface and an outer surface, said envelopeconfigured to enclose said implant; and a spacer disposed on at leastone of said inner surface or said outer surface of said envelope, saidspacer for positioning said implant at said anatomical site.
 2. Thesystem of claim 1 wherein said spacer comprises a bulk material.
 3. Thesystem of claim 2 wherein said bulk material comprises polyethylene. 4.The system of claim 2 wherein said bulk material comprises cellulose. 5.The system of claim 2 wherein said bulk material comprises hydrogel. 6.The system of claim 1 wherein said spacer comprises a balloon.
 7. Thesystem of claim 6 wherein said balloon contains a gas.
 8. The system ofclaim 6 wherein said balloon contains a liquid.
 9. The system of claim 1wherein said system further comprises a pressure sensor.
 10. The systemof claim 9 wherein said pressure sensor indicates the tension applied tothe envelope.
 11. The system of claim 1 wherein said spacer comprises aclamp.
 12. The system of claim 11 wherein said clamp comprises: a firstmember comprising a proximal end and a distal end, at least a firstexterior face extending therebetween, and a first thickness; and asecond member comprising a proximal end and a distal end, at least asecond exterior face extending therebetween, and a second thickness. 13.The system of claim 12 wherein the first thickness comprises the spacerthickness.
 14. The system of claim 12 wherein said clamp furthercomprises a balloon disposed on said first exterior face of said clamp.15. The system of claim 12 wherein said clamp further comprises a bulkmaterial disposed on said first exterior face of said clamp.
 16. Amethod for implanting an implant at an anatomical site in the body of apatient, comprising the steps of: providing a system comprising anenvelope comprising an inner surface and an outer surface, said envelopeconfigured to enclose said implant, and a spacer disposed on at leastone of said inner or said outer surface of said envelope; implantingsaid implant at said anatomical site in the body of a patient; andremoving said envelope from said patient.
 17. A system for implanting animplant at an anatomical site in the body of a patient, comprising: anenvelope means comprising an inner surface and an outer surface, saidenvelope means configured to enclose said implant; and a spacer meansdisposed on at least one of said inner surface or said outer surface ofsaid envelope means, said spacer means for positioning said implant atsaid anatomical site.